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

Model Number 07P7420

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

Patient identifier: multiple (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that a physician questioned falsely elevated alinity c lactate dehydrogenase ( (b)(4)) results on one patient.The results obtained from the samples from the same patient collected on (b)(6) 2020 were: sid (b)(6) 215.5 u/l, 212.1 u/l, 210.1 u/l; sid (b)(6) 243.1 u/l, 565.5 u/l, 226.0 u/l.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for ldh reagent lot 53885un20.Review of tracking and trending reports did not identify any related trends for the issue for the product.Return testing was not completed as returns were not available.The patient sample was retested on the same instrument and another alinity with acceptable results generated.File sample testing was not performed as the original sample generated correct results upon retesting.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 systemic issue or deficiency of the alinity c lactate dehydrogenase (ldh) reagent, lot number 53885un20 was identified.

• 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: 11010817
• MDR Text Key: 244397039
• Report Number: 3002809144-2020-01185
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• 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: 01/07/2021

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: 01/23/2021
• Device Model Number: 07P7420
• Device Catalogue Number: 07P74-20
• Device Lot Number: 53885UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01143; ALNTY C PROCESSING MODU, 03R67-01, AC01143