MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AAT2 TINA-QUANT ¿1-ANTITRYPSIN VER.2; ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL

Model Number AAT2

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2019

Event Type  malfunction  

Manufacturer Narrative

The qc results after the questionable patient results were not acceptable.The customer stated that when they removed the reagent back the reagent pack felt flimsy and was empty.The outside of the pack was wet which could have indicated the reagent pack leaked.The field engineering specialist inspected the cassette and did not believe the cassette was flimsy and he was not able to find any visible leaks or cracks.The field engineering specialist performed qc testing on the standby pack of reagent and the results were acceptable.He found no issues with the analyzer.He performed precision testing with acceptable results.The reagent cassette in question was requested for further investigation.The investigation is currently ongoing.

Event Description

The initial reporter complained of questionable aat2 tina-quant 1-antitrypsin ver.2 results for 6 patient's tested on a cobas 8000 c 502 module.From the data provided, 3 patients had discrepant results.For patient a the initial aat2 result was 1244.4 mg/dl with a repeat result of 145.7 mg/dl.For patient b the initial aat2 result was 1235.6 mg/dl with a repeat result of 179.8 mg/dl.For patient c the initial aat2 result was 938.6 mg/dl with a repeat result of 152.8 mg/dl.The results in question were reported outside of the laboratory.The repeat results were deemed correct.The initial patient results were from samples that were aliquoted by a modular pre-analytical system.The repeat results were from aliquots that were manually loaded.The cobas c502 serial number was (b)(4).

Manufacturer Narrative

The customer returned the reagent cassette for investigation.A leak test was completed with acceptable results.The investigation did not find any irregularities with the cassette.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: AAT2 TINA-QUANT ¿1-ANTITRYPSIN VER.2
• Type of Device: ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9152006
• MDR Text Key: 216377250
• Report Number: 1823260-2019-03553
• Device Sequence Number: 1
• Product Code: DEM
• Combination Product (y/n): N
• PMA/PMN Number: K010978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: AAT2
• Device Catalogue Number: 03005771322
• Device Lot Number: 37708101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1