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	08/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a.Patient information: no further patient information was provided by the customer.The complaint investigation for falsely elevated lactate dehydrogenase (ldh) results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.A review of tickets determined that there is normal complaint activity for ldh reagent lot 42231un20.Trending review did not identify any trends for falsely elevated results for the product.Quality control has been in range and the proficiency testing has been acceptable.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 42231un20 was identified.
Event or Problem Description
The customer observed falsely elevated lactate dehydrogenase (ldh) result generated on the architect c8000 processing module for one patient after the physician questioned the result.The following data was provided (normal range: 100 to 250 u/l): the patient had two samples drawn on (b)(6) 2020 and (b)(6) 2020 which generated results of 284 u/l and 500 u/l.The customer does not know which result goes to which date.A third sample was collected on (b)(6) 2020 and generated result of 171 u/l with the beckman analyzer.No impact to patient management was reported.

• 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: 11213993
• Report Number: 3002809144-2021-00046
• Device Sequence Number: 3658700
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 01/21/2021
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: 42231UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC C8 PROC MOD, 01G06-11, C804546