MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) LACTATE DEHYDROGENASE

Model Number	2P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt#1; pt#2; (b)(6) years; (b)(6) years; female; male.There was no additional patient information provided by the customer.Device evaluation: the evaluation of the customer issue for similar complaints by lot number could not be performed as the lot number is unknown.A review for trends by product code found no trends related to this issue.A review of labeling found the issue is adequately addressed.A review of the capa database found no trend was identified for the customer's issue.Based on all available information no product deficiency was identified.
Event or Problem Description
On (b)(6) 2020 customer provide additional information regarding their statement of false elevated architect lactate dehydrogenase (ldh) assay results for 2 patients.The customer provided: pt#1: (b)(6) year old female: initial = 195 u/l; repeat 714, 200 u/l; pt#2: (b)(6) year old male: initial = 244 u/l; repeat 331 u/l, 276 u/l (ref range: 140 to 280 u/l).It was also added that all results are from the same sample measured without further sample treatment.There was no impact to patient management reported.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10248374
• Report Number: 3016438761-2020-00116
• Device Sequence Number: 2228624
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/08/2020

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 Model Number: 2P56-21
• Device Catalogue Number: 02P56-21
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1