MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 111 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	C111
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer noted that the sample tube gel was inconsistent.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with crep2 creatinine plus ver.2 on a cobas c 111.The first patient sample initially resulted in a creatinine value of 1.66 mg/dl and repeated as 1.30 mg/dl.The 1.30 mg/dl value was reported outside of the laboratory to the patient.The patient was then tested in another laboratory and the creatinine result there was 0.69 mg/dl, so the patient complained about the result reported at the customer laboratory.The original sample was repeated two times on (b)(6) 2022, resulting in values of 0.68 mg/dl and 2.71 mg/dl.The second patient sample initially resulted in a creatinine value of 1.09 mg/dl and this value was reported outside of the laboratory to the patient.Due to the discrepancy with the first sample, the customer decided to repeat this sample.The sample was repeated twice on (b)(6) 2022, resulting in values of 0.83 mg/dl and 3.28 mg/dl.The third patient sample initially resulted in a creatinine value of 2.05 mg/dl and repeated as 1.20 mg/dl.The 1.20 mg/dl value was reported outside of the laboratory to the patient.Due to the discrepancy with the first sample, the customer decided to repeat this sample.The sample was repeated twice on (b)(6) 2022, resulting in values of 0.92 mg/dl and 3.26 mg/dl.The creatinine reagent lot number was 67082301, with an expiration date of 30-jun-2023.
Additional Manufacturer Narrative
The provided calibration data was within acceptable limits.Quality control recovery was acceptable.A reagent issue is not likely.The engineer noticed that the clotting time for the customer's serum tubes was insufficient.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: COBAS C 111 ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15927929
• Report Number: 1823260-2022-03910
• Device Sequence Number: 6563302
• Product Code: JJE
• UDI-Device Identifier: 04015630926862
• UDI-Public: 04015630926862
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K063744
• 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): 01/17/2023

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: C111
• Device Catalogue Number: 04528778001
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/17/2023
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 64 KG