MAUDE Adverse Event Report: ABBOTT LABORATORIES LACTATE DEHYDROGENASE

Catalog Number	02P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
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.An evaluation is in-process.
Event or Problem Description
The customer observed a falsely elevated lactate dehygrogenase (ldh) result while using the clinical chemistry ldh assay.The customer indicated the patient was admitted after the initial result was generated.The following results were provided: initial 1154, retest results: 214, 209 and 215 u/l no impact to patient management was reported.
Additional Manufacturer Narrative
The incorrect manufacturing location was documented in manufacturer name, city and state.Please refer to manufacture report number 1628664-2019-00286 for all further information.Device evaluated by mfr: an evaluation is in-process.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8411818
• Report Number: 1415939-2019-00014
• Device Sequence Number: 16625057
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 04/03/2019

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 Catalogue Number: 02P56-21
• Device Lot Number: 73199UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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: ARCHITECT C8000 PROCESS MODULE; ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(4); LN 01G06-11, SN (B)(4); ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(4)