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

Model Number 04V5131

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2020

Event Type  malfunction  

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 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.

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
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10979262
• MDR Text Key: 220706243
• Report Number: 3002809144-2020-01173
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740158422
• UDI-Public: 00380740158422
• Combination Product (y/n): N
• PMA/PMN Number: K121985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC03189; ALNTY C PROCESSING MODU, 03R67-01, AC03189