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

Catalog Number 08L92-41

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: ALANINE AMINOTRANSFERASE (ALT) IVD, REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6460302
• MDR Text Key: 71734182
• Report Number: 1628664-2017-00090
• Device Sequence Number: 1
• Product Code: CKA
• UDI-Device Identifier: 00380740017873
• UDI-Public: 00380740017873
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2017
• Device Catalogue Number: 08L92-41
• Device Lot Number: 62964UN16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM, LIST # 03L77-01,; SERIAL # (B)(4)
• Patient Outcome(s): Other