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	06/18/2018
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 observed falsely elevated lactate dehydrogenase (ldh) results while using the alinity c ldh assay.The customer provided the following results: on (b)(6) 2018: initial result: 1023.9 u/l, retest 157.1 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, design history record (dhr) review, a search for similar complaints, and a review of labeling.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.No other similar complaints were identified with this reagent lot number.Labeling was reviewed and found to be adequate.Based on the available information no deficiency of the alinity c lactate dehydrogenase assay, reagent list number 07p74, lot 60064un17, 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: 7635270
• Report Number: 3002809144-2018-00071
• Device Sequence Number: 16764731
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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: 07/04/2018
• Device Catalogue Number: 07P74-20
• Device Lot Number: 60064UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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 PROCESSING MODULE; ALINITY C PROCESSING MODULE; LN 03R67-01, SN (B)(4); LN 03R67-01, SN (B)(4)