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

Model Number	6L45-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The account generated false elevated architect total bilirubin results on 4 samples that repeated lower when processing on the architect c16000.The account uses a reference range of 3.4 to 20.5 umol/l.Sid (b)(6) (female, 32 year old, han/chinese) tested 1.7 repeated 7.2 umol/l.Sid (b)(6) (female, 29 year old, han/chinese) tested 1.40 repeated 12.4 umol/l.Sid (b)(6) (female, 28 year old, han/chinese) tested 3.1 repeated 8.1 umol/l.Sid (b)(4) (female, 29 year old, han/chinese) tested 0.8 repeated 7.2 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed to architect c16000, list 3l77 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2022-00592.All further information will be documented under mdr number 3016438761-2022-00592.After further evaluation, the suspect medical device was changed to architect c16000, list 3l77 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2022-00592.All further information will be documented under mdr number 3016438761-2022-00592.
Event or Problem Description
The account generated false elevated architect total bilirubin results on 4 samples that repeated lower when processing on the architect c16000.The account uses a reference range of 3.4 to 20.5 umol/l.Sid (b)(6) (female, 32 year old, han/chinese) tested 1.7 repeated 7.2 umol/l.Sid (b)(6) (female, 29 year old, han/chinese) tested 1.40 repeated 12.4 umol/l.Sid (b)(6) (female, 28 year old, han/chinese) tested 3.1 repeated 8.1 umol/l.Sid (b)(6) (female, 29 year old, han/chinese) tested 0.8 repeated 7.2 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15973138
• Report Number: 3002809144-2022-00436
• Device Sequence Number: 17629768
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/18/2022

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 Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 PRC MOD, 03L77-01, (B)(6) ; ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Female