MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALB2 ALBUMIN GEN.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Catalog Number	03183688122
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable alb2 albumin gen.2 results for one patient the cobas 6000 c501 module serial number (b)(4) compared to a competitor¿s platform.The reporter stated the same sample was tested on 3 cobas systems (twice on a 6000 and once on an 8000) and all three were non-comparable with the competitor platform.The reporter provided the following examples: the c501 result was 0.8 g/dl.The competitor result was 3.2 g/dl.The c501 result was 0.02 g/dl.The competitor result was 2.42 g/dl.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation found the calibration and qc data were within specifications which rules out a general reagent or instrument issue.An interference due to the drugs modafinil and azithromycin can be excluded as they do not violate the interference specification for alb2 in the therapeutic concentration.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ALB2 ALBUMIN GEN.2
• Common Device Name: BROMCRESOL GREEN DYE-BINDING, ALBUMIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12196697
• Report Number: 1823260-2021-02103
• Device Sequence Number: 3508744
• Product Code: CIX
• UDI-Device Identifier: 04015630918898
• UDI-Public: 04015630918898
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K033009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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 Catalogue Number: 03183688122
• Device Lot Number: 524225
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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: AZITHROMYZIN; BECOSULE (VIT B COMPLEX + VIT C); CALCIUM GLUCONATE; CANDID G-CELL-CREAM; CITISTAR (CITOCOLINE SODIUM); DEXORANGE; MODALERT (MODAFINIL); NEBCLEVOUN+BUDECORT; NUHENZ; PANTOCID (PANTROPRAZOLE); PETRIL MD (CLONAZEPAM); POTKLOR (POTASSIUM CHLORIDE); PROTEIN PLUS; REBAGEN (REBAMIPIDE); SHELCAL (CALCIUM AND VITAMIN D3); TOLVAS (TOLVAPTAN); UPRISE-D3 (VITAMIN D3 SUPPLEMENT)
• Patient Age: 76 YR