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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated lactate dehydrogenase results generated on the architect c8000 processing module for multiple samples.No specific patient information or data or comparison data was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
H6: component code: g01003.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.The issue appears to be sample specific for certain patient samples when the customer uses greiner tubes.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any related non-conformances or deviations with the likely cause list number and complaint issue.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 was identified.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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: 11580433
• Report Number: 3002809144-2021-00207
• Device Sequence Number: 14644229
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2021

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 Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 06/08/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 04/06/2021; 06/10/2021
• 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, C802808; ARC C8 PROC MOD, 01G06-11, C802808; ARC C8 PROC MOD, 01G06-11, C802808