MAUDE Adverse Event Report: ABBOTT GMBH LACTATE DEHYDROGENASE (LDH); NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Model Number 2P56-22

Device Problem High Test Results (2457)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.

Event Description

The customer reported falsely elevated ldh results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2020 (b)(6) initial ldh on serial number (b)(4) (normal range 125-220u/l) / retest on sn (b)(4).There was no reported impact to patient management.

Manufacturer Narrative

A review of similar complaint tickets could not be performed as the ldh reagent lot number was unknown.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.The patient sample was retested on the same instrument and acceptable results were generated.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 lactate dehydrogenase (ldh) reagent, list number 2p56 was identified.

• Brand Name: LACTATE DEHYDROGENASE (LDH)
• 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: 11077031
• MDR Text Key: 223789814
• Report Number: 3002809144-2020-01212
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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 Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600600; ARC C16K PRC MOD, 03L77-01, C1600600; ARC C16K PRC MOD, 03L77-01, C1600600