MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ACTIVATED ALANINE AMINOTRANSFERASE; ALANINE AMINOTRANSFERASE (ALT) IVD, REAGENT

Catalog Number	08L92-41
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that the architect analyzer is generating falsely elevated alt results on a liver transplant patient.The results provided were from two samples (same patient) tested on different analyzers: (b)(6) 2017 on c2 analyzer (b)(6) - alt = 16 / on c3 (sn (b)(4)) (b)(6) - alt = 86.No additional patient information was provided.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from activated alanine aminotransferase, list number 08l92-41, manufacturing site: abbott manufacturing inc, (b)(4) in this report to architect c16000 system; list number 03l77-01; manufacturing site: abbott manufacturing inc, (b)(4).Mdr number 1628664-2017-00122 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ACTIVATED ALANINE AMINOTRANSFERASE
• Common Device Name: ALANINE AMINOTRANSFERASE (ALT) IVD, REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6460302
• Report Number: 1628664-2017-00090
• Device Sequence Number: 563655
• Product Code: CKA
• UDI-Device Identifier: 00380740017873
• UDI-Public: 00380740017873
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2017
• Device Catalogue Number: 08L92-41
• Device Lot Number: 62964UN16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 04/21/2017
• 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 SYSTEM, LIST # 03L77-01,; SERIAL # (B)(4)
• Outcome Attributed to Adverse Event: Other