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

Catalog Number 06L45-21

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer indicated they were using lot numbers 50706uq01 and 51555uq07 during the timeframe of this event.It is unknown which lot generated the discrepant result.An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account stated falsely depressed architect total bilirubin results were generated compared to reference lab and other hospital results.Data was provided for case 2: the patient is a three days old female.On (b)(6) 2017, the patient generated a total bilirubin of >17 mg/dl at another lab.On unknown date, the patient generated architect total bilirubin of 6.6 mg/dl and the patient was discharged.On (b)(6) 2017, the patient generated a total bilirubin of >22.5 mg/dl at another lab and was sent the emergency room.On (b)(6) 2017, the patient generated a total bilirubin of 21.5 mg/dl at the emergency room and received photo therapy.The delay in photo therapy treatment did not harm or impact the patient.

Manufacturer Narrative

Lot is listed as unknown but multiple lot information, 51555uq07 and 50706uq01were provided.The account was using lots 51555uq07 and 50706uq01and it is unknown which lot is associated with which result.Evaluation is in process.

Manufacturer Narrative

In follow-up, submitted on 09nov2017, the incorrect manufacturing site was chosen in manufacturer name, city and state.This report is being submitted to correct it from (b)(4).The customer indicated they were using lot numbers 50706uq01 and 51555uq07 during the timeframe of this event.It is unknown which lot generated the discrepant result.An evaluation is still in process and a follow up will be submitted when the evaluation is complete.Evaluation is in process.

Manufacturer Narrative

The customer indicated they were using lot numbers 50706uq01 and 51555uq07 during the timeframe of this event.It is unknown which lot generated the discrepant result.Expiration date for lot 50706uq01 is 30jun2018 and 51555uq07 is 31dec2018.Device manufacture date for lot 50706uq01is 07apr2017 and 51555uq07is 01sep2017.Customer returns are not available for this issue.The assay used at the reference laboratory is the siemens advia vanadate oxidation method.For this investigation, testing was performed at abbott for linearity and interference.Additional testing of ceqal proficiency samples, linearity, method comparison, and interference was performed at the customer site.The testing completed at abbott and customer site found: method comparison confirms siemens recovers higher at higher concentrations.Traceability testing shows abbott aligned closer to doumas reference method (gold standard).Linearity study with gravimetric preparations show abbott under recovers approximately 1 to 6%, siemens over recovers up to 10%.Interference results at abbott show no interference with hemoglobin, intralipid, and triglyceride at levels tested.Interference sample aliquots shipped to customer site appear compromised.Results obtained are not aligned with in-house testing.Review of product labeling found adequate information regarding interpretation of results and troubleshooting this issue.A ticket search by product lot found no other complaints similar to the current complaint issue.No adverse or non-statistical trends were found over the past 12 months related to this issue.The customer's qc and proficiency results for this assay were within expected ranges.In addition, review of peer group data for the cap c-b 2017 survey shows the vanadate oxidation method generated slightly higher results than the architect diazonium salt and all method assays.The trend review and lot search did not identify an increase in complaint activity for the current issue.Taken together, no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Type of Device: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6927337
• MDR Text Key: 89948720
• Report Number: 1628664-2017-00374
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06L45-21
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/07/2017
• Supplement Dates Manufacturer Received: 10/18/2017; 12/05/2017; 12/28/2017
• Supplement Dates FDA Received: 11/09/2017; 12/12/2017; 01/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 DA