MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number 07P9920

Device Problem High Test Results (2457)

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

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.No patient information is available.

Event Description

The account generated false elevated alinity c creatinine of 2.7 mg/dl on sid (b)(6) that repeated 0.66 mg/dl.The sample was repeated on another alinity analyzer with normal results.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 55012un19.Trending review determined no adverse trend for falsely elevated 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.Review in the corrective and preventive actions system did not identify any non-conformances or deviations related to the to the complaint list number, lot number and complaint issue.No product deficiency was identified for the alinity c creatinine reagent lot 55012un19.Section d.4.Catalog# updated from 07p99-20 to 07p99-30.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10659282
• MDR Text Key: 233891878
• Report Number: 3002809144-2020-01014
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• PMA/PMN Number: K083809
• 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: 11/08/2020

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: 01/07/2021
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-30
• Device Lot Number: 55012UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 11/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC02110; ALNTY C PROCESSING MODU, 03R67-01, AC02110