MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received an erroneous result for one patient sample tested for crep2 creatinine plus ver.2 on a cobas 6000 c (501) module - c501.The customer stated that there were no clots or fibrin in the sample.The sample initially resulted with a crep2 value of 3.49 mg/dl and this value was reported outside of the laboratory.The sample was repeated, resulting as 0.93 mg/dl.No adverse events were alleged to have occurred with the patient.The crep2 reagent lot number was 32825201, with an expiration date of 31-dec-2018.A general reagent issue could be ruled out since calibration and controls are acceptable.
Additional Manufacturer Narrative
The field service engineer checked the analyzer wash station levels and these were ok.The customer has not reported any additional issues.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 6000 C (501) MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7766976
• Report Number: 1823260-2018-02664
• Device Sequence Number: 2061417
• Product Code: JJE
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K060373
• 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,Followup
• Report Date (Section B): 10/29/2018

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
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 07/24/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/21/2018; 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR