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

Model Number 04V5131

Device Problem Low Test Results (2458)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported a false decreased alinity c total bilirubin result for one patient.The customer provided the clinician questioned the initial result for (b)(6) of 51umol/l as it did not fit with the patient history.The repeat of 300umol/l does fit the patient history.There was no reported impact to patient management.

Manufacturer Narrative

The evaluation of the customer¿s issue included a search for similar complaints, trending review, and labeling review.A review of tickets determined that there is normal complaint activity for alinity c total bilirubin (ln 04v51-31) lot 57727uq06.Trending review determined no trend for falsely depressed results for the product.Return testing was not completed as returns were not available.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: 10946833
• MDR Text Key: 241306577
• Report Number: 3002809144-2020-01158
• 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: 01/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 04V5131
• Device Catalogue Number: 04V51-31
• Device Lot Number: 57727UQ06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01970; ALNTY C PROCESSING MODU, 03R67-01, AC01970