MAUDE Adverse Event Report: ABBOTT GMBH LACTATE DEHYDROGENASE

Model Number	2P56-42
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated lactate dehydrogenase (ldh) result when processing on the architect c16000.The initial result was 514 u/l and retest was 198 u/l.Retesting on another instrument yielded results of 195, 7, and 197 u/l.The customer uses a reference range of 125-220 u/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Upon retrospective review an error was identified with section d of this report: d3 (abbott gmbh) and d4 (02p56-42).The correct manufacturer location should be abbott laboratories (irving/atm) and the correct list number should be 02p56-21.This correction has been submitted in manufacturer report number 1628664-2020-00109.Any future information regarding this event will be submitted under manufacturer report number 1628664-2020-00109.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9682538
• Report Number: 3002809144-2020-00096
• Device Sequence Number: 2778072
• Product Code: CFG
• UDI-Device Identifier: 00380740161477
• UDI-Public: 00380740161477
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/01/2020

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: 08/06/2020
• Device Model Number: 2P56-42
• Device Catalogue Number: 02P56-42
• Device Lot Number: 40988UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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: ARCHITECT C16000 ANALYZER; ARCHITECT C16000 ANALYZER; LN 03L77-01, SN (B)(4); LN 03L77-01, SN (B)(4)