MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C TOTAL BILIRUBIN REAGENT KIT; DIAZO COLORIMETRY, BILIRUBIN

Model Number	04V5131
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false elevated alinity c total bilirubin results for neonates compared to the gasometer (b)(4), radiometer-spectrophotometry).The customer provided the following for four patients: sid: (b)(6): initial = 15.53 mg/dl, repeat 15.96 mg/dl, and gasometer = 11.5 mg/dl; sid: (b)(6): initial = 15.28 mg/dl, repeats = 14.92 mg/dl, 13.25 mg/dl(dil 1:5), 12.43 mg/dl (dil 1:10), & gasometer 11.6 mg/dl; sid: (b)(6): initial = 14.42 mg/dl, and gasometer = 11.2 mg/dl; sid: (b)(6): initial = 15.42 mg/dl, and gasometer = 11.9 mg/dl.There was no reported impact to patient management there was no reported impact to patient management.
Additional Manufacturer Narrative
The evaluation of the customer¿s issue included a search for similar complaints, ticket trending review, labeling review, device history record review.A review of tickets determined that there is normal complaint activity for lot 57809uq07.Trending review determined no trend for falsely elevated results for the product.Return testing was not completed as returns were not available.The customer reports that all alinity total bilirubin quality control results are within expected ranges; this appears to be a patient sample specific event.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 all available information no systemic issue or product deficiency was identified.

• Brand Name: ALINITY C TOTAL BILIRUBIN REAGENT KIT
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10979262
• Report Number: 3002809144-2020-01173
• Device Sequence Number: 17208111
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: 00380740158422
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (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): 01/05/2021

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: 03/30/2021
• Device Model Number: 04V5131
• Device Catalogue Number: 04V51-31
• Device Lot Number: 57809UQ07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC03189; ALNTY C PROCESSING MODU, 03R67-01, AC03189