MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
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	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's tpu3 initial result was accompanied by a data flag that invalidated the result.This indicates a very high concentration level in the patient sample.The customer reran the patient samples five times in normal mode.The results were 63.68 mg/dl, 67.24 mg/dl, 69.10 mg/dl, 68.47 mg/dl and 64.45 mg/dl.All of the results were accompanied by a data flag that invalidated the results.The customer has now implemented a rule in their middleware blocking urine alb-t results when the tpu3 results are flagged.The customer stated that the patient sample was not recentrifuged after being thawed from the freezer before it was rerun.The customer stated that it was a little cloudy when it was frozen.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable albt2 tina-quant albumin gen.2 result for one urine patient sample tested on the cobas 6000 c 501 module.The initial result was reported outside of the laboratory.The doctor questioned the result which promote a rerun of the patient sample.On (b)(6) 2022, the initial result was 14.66 mg/dl.On (b)(6) 2022, the first repeat result was 67.98 mg/dl with a data flag that invalidated the result.The second repeat result using decreased mode was 414.92 mg/dl.This repeat result was deemed correct.The reagent lot number is 641706.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The expiration date of the albt2 reagent is 29-feb-2024.Based on the customer's repeated measurements of the sample, the investigation verified that the prozone check works.The investigation did not identify a product problem.The cause of the event could not be determined. .

• Brand Name: COBAS 6000 C501 MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15620462
• Report Number: 1823260-2022-03218
• Device Sequence Number: 20389596
• Product Code: JJE
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 11/11/2022

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 Model Number: C501
• Device Catalogue Number: 04745914001
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/11/2022
• 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
• Patient Sex: Unknown