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 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

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 observed falsely elevated creatinine results on the alinity analyzer.The following data was provided (umol/l): sid (b)(6) initial 184.7, repeat 150, sid (b)(6) initial 201.1, repeat 106.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the design history file, review of field data, and a review of labeling.No adverse trend, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.No return patient sample was available.Labeling was reviewed and found to be adequate.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected limits.Accurate and reproducible results are dependent upon properly functioning instruments and reagents, storage of product as directed, and good laboratory technique.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• 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: 9377861
• MDR Text Key: 218522522
• Report Number: 3002809144-2019-00975
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: 11/05/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY ANALYZER.; ALINITY ANALYZER.; LN 03R67-01 SN (B)(4).; LN 03R67-01 SN (B)(4).