MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBT2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	04469658190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation reviewed the provided qc and no abnormalities were found.The investigation reviewed the system alarm trace and found "sample aspiration" alarms.The patient's sample was provided for an investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable urine albt2 tina-quant albumin gen.2 (microalbumin) results for one patient tested on a cobas 8000 c 502 module with serial number (b)(4).The patient's initial microalbumin result was reported outside the laboratory.The patient's doctor did not believe the reported microalbumin result.The customer performed repeat testing with the patient's sample on the c 502 module and an optilite analyzer.On (b)(6) 2022, the patient's initial microalbumin result was 0.247 g/l.On (b)(6) 2022, the patient's microalbumin result on the optilite analyzer was 6.8 g/l.On (b)(6) 2022, the patient's repeat microalbumin result was 0.223 g/l.This result was reported to the patient's doctor.On (b)(6) 2022, the patient's repeat microalbumin result with a 1:11 dilution was 6.277 g/l with a data flag.On (b)(6) 2022, the patient's repeat microalbumin result with a 1:50 dilution was 6.879 g/l.The customer determined the correct results for the patient were 6.8 g/l, 6.277 g/l, and 6.879 g/l.
Additional Manufacturer Narrative
The investigation could not reproduce the customer's results.The investigation tested the patient's sample without dilution and a valid albumin result could not be produced due to a data flag.The investigation tested the patient's sample with a 1:11 (decreased mode) and a 1:10 dilution and the albumin results were 5207.6 mg/l with a data flag and 5385.9 mg/l with a data flag.The investigation tested the patient's sample with a 1:20 and a 1:50 dilution, and the patient's results were 5190.7 mg/l and 4680.0 mg/l, which were comparable with the measurement of the optilite analyzer.The investigation did not identify a product problem.

• Brand Name: ALBT2
• Common Device Name: ALBUMIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14322882
• Report Number: 1823260-2022-01310
• Device Sequence Number: 20117989
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K101203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 07/31/2023
• Device Catalogue Number: 04469658190
• Device Lot Number: 583232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: (B)(6)
• Patient Sex: Female