MAUDE Adverse Event Report: ABBOTT GERMANY LACTATE DEHYDROGENASE

Catalog Number	07P74-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity lactate dehydrogenase (ld/ldh) results for a sample were generated on the alinity c analyzer.The customer reported the sample generated sid (b)(6) initial result of 4154 u/l, with a retest result of 730 u/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8384765
• Report Number: 3002809144-2019-00080
• Device Sequence Number: 2105177
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 05/24/2019

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: 03/22/2019
• Device Catalogue Number: 07P74-20
• Device Lot Number: 66140UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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: ALINITY C ANALYZER; ALINITY C ANALYZER; LN 03R67-01 SN (B)(4). ; LN 03R67-01 SN (B)(4).