MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C LACTATE DEHYDROGENASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Model Number 07P7430

Device Problem High Test Results (2457)

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.

Event Description

The customer reported falsely elevated ldh results generated on the alinity c analyzer on multiple patients.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for alinity c lactate dehydrogenase (ldh) reagent list number 07p74-30, lot number 83390un20.Trending review determined no trends for falsely elevated results for the product.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.The search did not show any related potential non-conformances, deviations, or non-conformances.Based on the investigation no product deficiency was identified for the alinity c lactate dehydrogenase (ldh) reagent list number 07p74-30, lot number 83390un20.

• Brand Name: ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
• Type of Device: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10970156
• MDR Text Key: 231440093
• Report Number: 3002809144-2020-01166
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740130251
• UDI-Public: 00380740130251
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/11/2021

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: 03/30/2021
• Device Model Number: 07P7430
• Device Catalogue Number: 07P74-30
• Device Lot Number: 83390UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01883.; ALNTY C PROCESSING MODU, 03R67-01, AC01883.