MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Model Number 07P7220

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).An evaluation is in process.A follow up will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated alinity c carbon dioxide results for multiple samples on (b)(6) 2021.The samples generated initial results ranging from 35 to 45 meg/l which did not match historical results.The following example data was provided (customer¿s range is 22 to 29 meg/l): (b)(6).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c carbon dioxide results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.As part of troubleshooting the customer recalibrated the assay with a new calibrator lot and quality control (qc) results were reported to be within the expected ranges.The samples with questionable results were repeated, and most of them came out around 10 points lower.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 07p72 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c carbon dioxide for lot 58588uq11 was identified.

Event Description

The customer observed falsely elevated alinity c carbon dioxide results for multiple samples on 14oct2021.The samples generated initial results ranging from 35 to 45 meg/l which did not match historical results.The following example data was provided (customer¿s range is 22 to 29 meg/l): sid (b)(6) initial result = 34, repeat after recalibration = 26.7 meg/l sid (b)(6) initial result = 37.1, repeat after recalibration = 23.3 meg/l sid (b)(6) initial result = 35, repeat after recalibration = 26.6 meg/l sid (b)(6) initial result = 35.4, repeat after recalibration = 22.9 meg/l no impact to patient management was reported.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Type of Device: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12883483
• MDR Text Key: 282972076
• Report Number: 3002809144-2021-00678
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 07P7220
• Device Catalogue Number: 07P72-20
• Device Lot Number: 58588UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)