MAUDE Adverse Event Report: ABBOTT GMBH TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	06L45-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids (sample id) (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c16000 for multiple patient samples.The following data was provided (customer¿s reference range <20 umol/l): sample id (b)(6) initial result = 227 umol/l, repeat = 9 umol/l; sample id (b)(6) initial result = 219 umol/l, repeat = 6 umol/l; sample id (b)(6) initial result = 59 umol/l, repeat = 9 umol/l; sample id (b)(6) initial result = 159 umol/l, repeat = 18 umol/l; sample id (b)(6) initial result = 85 umol/l, repeat = 6 umol/l; sample id (b)(6) initial result = 84 umol/l, repeat = 10 umol/l; sample id (b)(6) initial result = 44 umol/l, repeat = 4 umol/l; sample id (b)(6) initial result = 56 umol/l, repeat = 6 umol/l; sample id (b)(6) initial result = 62 umol/l, repeat = 11 umol/l; sample id (b)(6) initial result = 135 umol/l, repeat = 19 umol/l; sample id (b)(6) initial result = 76 umol/l, repeat = 14 umol/l; sample id (b)(6) initial result = 84 umol/l, repeat = 9 umol/l; sample id (b)(6) initial result = 96 umol/l, repeat = 10 umol/l; sample id (b)(6) initial result = 66 umol/l, repeat = 8 umol/l; sample id (b)(6) initial result = 74 umol/l, repeat = 6 umol/l; sample id (b)(6) initial result = 114 umol/l, repeat = 10 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect total bilirubin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Ticket and trending review did not identify trends for the complaint issue.Device history record review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and found to sufficiently address the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the architect total bilirubin reagent lot 62230uq06, was identified.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c16000 for multiple patient samples.The following data was provided (customer¿s reference range <20 umol/l): sample id (b)(6) initial result = 227 umol/l, repeat = 9 umol/l.Sample id (b)(6) initial result = 219 umol/l, repeat = 6 umol/l.Sample id (b)(6) initial result = 59 umol/l, repeat = 9 umol/l.Sample id (b)(6) initial result = 159 umol/l, repeat = 18 umol/l.Sample id (b)(6) initial result = 85 umol/l, repeat = 6 umol/l.Sample id (b)(6) initial result = 84 umol/l, repeat = 10 umol/l.Sample id (b)(6) initial result = 44 umol/l, repeat = 4 umol/l.Sample id (b)(6) initial result = 56 umol/l, repeat = 6 umol/l.Sample id (b)(6) initial result = 62 umol/l, repeat = 11 umol/l.Sample id (b)(6) initial result = 135 umol/l, repeat = 19 umol/l.Sample id (b)(6) initial result = 76 umol/l, repeat = 14 umol/l.Sample id (b)(6) initial result = 84 umol/l, repeat = 9 umol/l.Sample id (b)(6) initial result = 96 umol/l, repeat = 10 umol/l.Sample id (b)(6) initial result = 66 umol/l, repeat = 8 umol/l.Sample id (b)(6) initial result = 74 umol/l, repeat = 6 umol/l.Sample id (b)(6) initial result = 114 umol/l, repeat = 10 umol/l.No impact to patient management was reported.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18075432
• Report Number: 3002809144-2023-00460
• Device Sequence Number: 7665846
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2023
• Device Catalogue Number: 06L45-42
• Device Lot Number: 62230UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K REFURB-SEKAT, 03L77-97, (B)(6). ; ARC C16K REFURB-SEKAT, 03L77-97, (B)(6).
• Patient Sex: Unknown