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 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).There was no additional patient information provided by the customer due to privacy issues.A review of tickets determined that there is not an increase in complaint activity for ldh reagent lot 02747un20.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.File sample testing was not performed as the original sample generated correct results upon retesting.Quality control has been in range at the time of the incident.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, lot number 02747un20, was identified.

Event Description

The customer reported falsely elevated lactate dehydrogenase (ldh) results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2021 (b)(6) initial = 1563.0u/l (normal range 125-220u/l) / retest = 147 and 148u/l.There was no reported impact to patient management.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 11215775
• MDR Text Key: 256683096
• Report Number: 3002809144-2021-00047
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1