MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Model Number 6L45-21

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepant bilirubin results while using the clinical chemistry total bilirubin assay on the architect c4000 analyzer.The following data was for 2 infant patients: patient 1: 22, retest 11; patient 2: 2.8, retest 13.2.There has been no impact to patient management reported.

Manufacturer Narrative

The original data reported was clarified by the customer with sample ids, dates of testing and an update to the originally reported data.Further investigation of the customer issue included a review of the complaint text, design history review, a search for similar complaints, and a review of labeling.Return material was not available.A design history review did not find any non-conformances or deviations with the lot number in question.Tracking and trending did not identify an adverse trend for discrepant total bilirubin results.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the clinical chemistry total bilirubin assay, ln 06l45, lot 51555uq07, was identified.

Event Description

The customer observed discrepant bilirubin results while using the clinical chemistry total bilirubin assay on the architect c4000 analyzer.The following data was for 2 infant patients: patient 1 (sid (b)(6)): (b)(6) 2017: initial 22.7, (b)(6) 2017 retest 11.6.Patient 2: (sid (b)(6) ): (b)(6) 2018: initial 2.8, (no barcode tested under the name kara) retest 13.2.There has been no impact to patient management reported.

Manufacturer Narrative

The customer observed discrepant results for two infant patient samples when using total bilirubin reagent, lot 51555uq07 on architect (b)(4).The customer concluded that there were sample integrity issues as these samples were poured from pediatric collection tubes.A search of complaints found no similar complaints for the customer's issue for total bilirubin reagent, lot 51555uq07 and no trends were identified.A review of assay product labeling found adequate information regarding interpretation of results and troubleshooting of the complaint issue.In addition, the architect operations manual provides multiple probable causes for erratic results such as: sample contains fibrin clots or particulate matter, bubbles or foam are on the surface of the sample, sample was not collected/prepared correctly, and sample volume in cup or tube was inadequate.Samples that are not handled properly may generate incorrect results.Manufacturer's instructions must be followed for both tubes and centrifuges as serum and plasma samples may generate inaccurate values if not centrifuged according to manufacturer's specifications.Use error may have contributed to the customer's issue due to potential sample handling issues.Based on the investigation no product deficiency was identified for the total bilirubin reagent, list number 6l45-21, lot 51555uq07.A product correction letter was issued on 17jul2018 to all architect clinical chemistry customers notifying them to adhere to the labeling instructions listed in the architect operations manual, section 10, to resolve error codes 3580 to 3585 or 5381 before transitioning the architect to the running status.The product correction letter provides guidance on how the customer can ensure the pressure monitoring system is functioning, and recommends following the architect systems operations manual and the assay-specific documentation to ensure all samples and reagents meet described requirements before being placed on the architect.The investigation into this event identified that when the pressure monitor board communication on the architect clinical chemistry analyzer is not successfully established during initial instrument boot up, and the following error codes 3580 to 3585 or 5381 are not resolved by the user prior to transitioning the architect to the running status, there is the potential to generate incorrect results as the pressure monitoring system is inactive.The architect system software will be updated in a future version to prevent the architect analyzer from transitioning to the running status when the pressure monitoring system is in an error state.

Manufacturer Narrative

This follow-up report is being filed to provide additional details of the product evaluation that was provided on 02/15/2018.Return reagent material was not available.The customer indicated they suspected the incorrect results were generated due to a sample integrity issue since the specimens were poured over from pediatric collection tubes.Quality control results were within range when the testing was completed.A historical data review was completed.This review consisted of a lot review, an adverse trend review and a tracking and trending review.The lot review identified one additional complaint with a generated discrepant result; however, the complaint was not similar to the event documented in this mdr reportable event.The trend review did not identify any adverse trends for ln 06l45 (clinical chemistry total bilirubin) during the previous 12 months.An instrument log review was completed.This review confirmed and clarified the data the customer provided to abbott diagnostics division.Additionally, the log review identified four occurrences of level sense error code (3004) being generated for other assays on this specimen immediately after the initial test result on (b)(6) 2018 was generated.Product labeling was highlighted to the customer as error code 3004 may be caused by samples containing fibrin clots or particulate matter, bubbles or foam on the surface of the sample, the sample not being collected/prepared correctly, and the sample volume in the cup or tube was inadequate.The error code being generated suggests that the issue was due to sample integrity.A design history review did not find any nonconformances or deviations with the product in question over the previous 12 months.Release testing for lot 51555uq07 met all specifications and release criteria.Labeling was reviewed and found to provide adequate information regarding interpretation of results and troubleshooting this issue.Our evaluation is consistent with the customers conclusion that the discrepant bilirubin results on 12/05/17 and 01/02/18 were likely due to sample integrity and/or handling issues.On 02/02/18 additional information on the instrument system was obtained, and it was noted that the operator was presented twelve (12) error codes 3580 (pm board not in ready mode) between 11/7/2016 and 1/8/2018.The corrective action described in the operators manual for error code 3580 is to cycle power to the instrument to restore communication, and to contact abbott customer support to resolve any hardware failures.In light of this new information, a second manufacturer report (1628664-2018-00122) has been submitted for the architect c4000 analyzer.Based on the available information no product deficiency of the clinical chemistry total bilirubin assay, ln 06l45, lot 51555uq07, has been identified.All further evaluation of the architect c4000 analyzer will be documented in manufacture report number 1628664-2018-00122.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Type of Device: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7222862
• MDR Text Key: 98739213
• Report Number: 1415939-2018-00014
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: (01)00380740011369(17)181231(10)51555UQ07
• Combination Product (y/n): N
• PMA/PMN Number: K060574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 51555UQ07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1628664-07/17/18-001-C
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-01, SN (B)(4); LN 02P24-01, SN (B)(4); LN 02P24-01, SN (B)(4); LN 02P24-01, SN (B)(4)