MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CREATININE

Catalog Number 07P99-30

Device Problem High Test Results (2457)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information, patient identifier: multiple = sid (b)(4), sid (b)(4).All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated creatinine results on one patient.The results provided were: on 20aug2019 sid (b)(4) creat = 13.98mg/dl / on 21aug2019 new draw (sid (b)(4)) in er = 0.69mg/dl; on a second analyzer serial number (b)(4) the 20aug2019 sample = 12.66mg/dl.There was no reported impact to patient management.

Manufacturer Narrative

A ticket search by lot 64125un18 found normal complaint activity and no trends were identified related to this issue.Return testing was not completed as returns were not available.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 the investigation no product deficiency was identified for the alinity c creatinine, lot 64125un18.

• Brand Name: ALINITY C CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9088411
• MDR Text Key: 189352848
• Report Number: 3002809144-2019-00565
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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: 01/15/2020
• Device Catalogue Number: 07P99-30
• Device Lot Number: 64125UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C PROCESSING MODULE, LN 03R67-01,; ALINITY C PROCESSING MODULE, LN 03R67-01,; SERIAL # (B)(4).; SERIAL # (B)(4).