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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No customer returns were available for evaluation.A review of ticket trending and product lot number (55176un18) search did identify two additional complaints that were similar for falsely elevated ldh patient results.In both cases, only one sample was involved and both samples were repeated and found to be in the normal range.The trend review by the product list number found no adverse or non-statistical trends related to this issue.Labeling was reviewed and found to adequately address the issue under review.No product deficiency was identified.Section a.Patient information: sids sequentially starting at (b)(6); all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated ldh results generated on the architect analyzer for multiple health fair patients.163 patient samples were processed, sids sequentially starting at (b)(6).Per the customer, 90% of patient results were greater than 220 u/l; 60% of patient results were greater than 241 u/l (normal range: 125-220 u/l).No 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: 8789885
• Report Number: 1628664-2019-00499
• Device Sequence Number: 19499657
• Product Code: CFG
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/15/2019
• 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 C4000 ANALYZER LIST 02P24-40; SERIAL (B)(4).