MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC 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	06/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.Historical quality metrics were reviewed, and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The instrument history log shows that from (b)(6) 2019 through (b)(6) 2019 there are 35 occurrences of error code 0550, cuvette washing not completed error.No errors occurred at the time the abnormal low results were tested.A system factor that may impact results is the failure to allow cuvette washing to complete, resulting in dirty cuvettes and cuvette dryer tips.Incomplete cuvette washing will generate error code 0550.The issues that triggered these errors can contribute to, or cause, the discrepant results issue observed.Based on the available information, no product deficiency was identified.
Event or Problem Description
The customer observed imprecision on the architect c16000 system.Sid (b)(6): ldh result of 267 u/l retested at 132.No adverse impact to patient management was reported.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8808523
• Report Number: 1628664-2019-00514
• Device Sequence Number: 343250
• Product Code: CFG
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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
• Report Date (Section B): 07/19/2019

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: 12/06/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 55176UN18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1