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

Complete information for section a patient information, 1.Patient identifier = sid= (b)(4) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated lactate dehydrogenase (ldh) results on architect c16000 processing module for one patient.The results provided were: on (b)(6) 2020 sid (b)(6) initial ldh= 371 u/l /repeated=582 u/l /repeated=366 u/l and 380 u/l.There was no reported impact to patient management.

Manufacturer Narrative

A review of complaints found no trends for the complaint issue.Return testing was not completed as returns were not available.No file sample testing performed as the issue is sample / tube specific at the customer site; the customer generated acceptable results using the same reagent.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and multiple probable causes were identified: handle specimen collection and sample tube processing per the tube manufacturer's instructions.So handled, plasma may still contain cellular elements which can interfere with the ldh measurements due to presence of the enzyme in the cells or cellular debris or sample handling issues.Based on the investigation no product deficiency was identified for the lactate dehydrogenase (ldh) assay reagent, lot 02747un20.

• 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: 11080353
• MDR Text Key: 241307352
• Report Number: 3002809144-2020-01206
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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: 06/16/2021
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: 02747UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600596; ARC C16K PRC MOD, 03L77-01, C1600596