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

Model Number	6L45-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier does not contain enough spaces, the entire id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated false depressed architect total bilirubin on a pediatric patient (male, (b)(6) old, (b)(6) ethnicity) processed on the architect c16000.On (b)(6) 2021, the sid (b)(6) generated architect total bilirubin of 22 mmol/l.On (b)(6) 2021, the same patient with sid (b)(6) generated architect total bilirubin of 374 mmol/l and sid (b)(6) of 356 mmol/l.No specific patient information was provided.No impact to patient management was reported.
Event or Problem Description
Additional information provided.The account confirmed that the sample is a pediatric sample and volume was short.
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Per ticket notes, service has confirmed to customer that the sample was short and it sampled from bottom of cup so incorrect volume aspirated without error as pressure is built up from bottom of cup.An lls error would generate on next attempt to run from sample.A search for similar tickets was performed and the review found only this ticket for this lot number.A review for complaint trends for the list number was performed and the review did not identify any trends associated with this list number.Review of non-conformances or deviations for the past 12 months found no non-conformance related to this issue.Labeling is adequate and provides specific instructions to the customer regarding the current issue.A user error cannot be ruled out as customer performed testing outside of abbott's specifications.To further investigate the customer¿s issue, the historical performance of reagent lot 58701uq12 was evaluated using worldwide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 58701uq12 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 58701uq12.A product deficiency was not identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12239785
• Report Number: 3002809144-2021-00450
• Device Sequence Number: 17159370
• 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): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 6L45-42
• Device Catalogue Number: 06L45-42
• Device Lot Number: 58701UQ12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 10/06/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/12/2021; 10/08/2021
• 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 PRC MOD, 03L77-01, C1600671; ARC C16K PRC MOD, 03L77-01, C1600671; ARC C16K PRC MOD, 03L77-01, C1600671
• Patient Age: 15 DA