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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complete id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation is in process.
Event or Problem Description
The account generated falsely elevated architect ldh of 504 u/l that repeated 154 and 156 u/l with sid (b)(6).No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
The instrument history log shows that from 01apr2019 through 17jun2019 there are 208 occurrences of error code 0550 cuvette washing not completed error, hardware failure or user pressed stop, and 543 occurrences of error code 3375 unable to process test, aspiration error occurred.The maintenance log shows periodic maintenance was performed as required; however, the as-needed maintenance procedure 6052 wash cuvettes was not performed following any of the occurrences of error code 0550 as instructed in the architect operations manual.The quality control log review of oct 2018 through june 2019 shows quality control in range.The trend review by the product list number found no adverse trends related to this issue.A device history review showed no issues that were associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.No customer return was available for evaluation.No product deficiency was identified.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8814559
• Report Number: 1628664-2019-00516
• Device Sequence Number: 11540473
• Product Code: CFJ
• 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,Followup
• Report Date (Section B): 08/21/2019

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?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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 C16000 LIST 03L77-01; ARCHITECT C16000 LIST 03L77-01; SERIAL: (B)(6).; SERIAL: (B)(6).; ARCHITECT C16000 LIST 03L77-01; SERIAL (B)(4)