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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

The account generated (b)(6) architect ldh that repeated lower.A patient sample generated architect ldh of (b)(6) that repeated (b)(6).The account ldh normal expected range is 162 to 243 u/l.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The investigation included review of complaint activity, trending reports, device history records and labeling.Return testing was not completed as returns were not available.The customer retested the sample and generated the expected lower normal results.Additionally, the customer's quality controls were in range indicating the assay was performing as expected.Review of complaint and trending data did not identify any issues or trends.Device history records for the complaint lot were reviewed and did not identify any issues related to the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency was identified for the architect ldh reagent lot.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13827305
• MDR Text Key: 289485047
• Report Number: 3002809144-2022-00099
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 04/26/2022

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: 04/08/2022
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: 14071UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C804340.; ARC C8 PROC MOD, 01G06-11, C804340.