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	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.Patient information: no further information was provided.This issue was previously reported under mdr number 3016438761-2021-00151 under the same suspect medical device but an incorrect manufacturer name, city and state.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained a falsely depressed architect total bilirubin result.On (b)(6) 2021 sample id (b)(6) generated 16.4 and repeat 117 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot number 58020uq08.Trending review for the architect total bilirubin assay determined there were no trends for false depressed patient results.Return testing was not completed as returns were not available.The complaint data states the customer is happy with instrument performance and believes the sample was short as it was pediatric sample.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect total bilirubin reagent lot 58020uq08 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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: 11756820
• Report Number: 3002809144-2021-00282
• Device Sequence Number: 3192644
• 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
• Report Date (Section B): 05/26/2021

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: 01/31/2022
• Device Model Number: 6L45-42
• Device Catalogue Number: 06L45-42
• Device Lot Number: 58020UQ08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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, (B)(4); ARC C16K PRC MOD, 03L77-01, (B)(4)