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

Model Number	2P56-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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)
• Common Device Name: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11215775
• Report Number: 3002809144-2021-00047
• Device Sequence Number: 14367086
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1