MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C111; CLINICAL CHEMISTRY ANALYZER

Model Number	C111
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer found the ise faraday cage was not securely locked into place and the dosage pipette locking screw was not tight.He corrected the faraday cage and dosage pipette, performed various checks and precision testing.The qc was within lab guidelines.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ise indirect na, k, for gen.2 results for one patient sample with the cobas c 111.The initial na result was 129 mmol/l.The repeated result per laboratory policy was 129 mmol/l.The patient was sent to another facility and received a na result of 139 mmol/l.The customer repeated the sample a second time with a na result of 129 mmol/l.The sample was sent to a sister laboratory and tested with a cobas 6000 with a na result of 137 mmol/l.The initial k result was 4.1 mmol/l.The repeated result was 4.7 mmol/l.The questionable results were reported outside the laboratory.The repeated results (na of 137 mmol/l and k of 4.7 mmol/l) were deemed correct.The na electrode lot number was 21511663 with an expiration date of 22-oct-2021.The k electrode lot number was 21511165 with an expiration date of 17-sep-2021.
Additional Manufacturer Narrative
Based on the pre-analytic information provided, the investigation discovered 2 deviations: rack adapters were not used centrifuge time 10 minutes /speed 5000 rpms.The speed was too high.The available data indicate that a mis-sampling of the patient sample most likely took place.These effects are caused mainly by poor sample quality.The investigation determined the event was consistent with a pre-analytical sample handling issue at the customer site.

• Brand Name: COBAS C111
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12567244
• Report Number: 1823260-2021-02882
• Device Sequence Number: 3193388
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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 Model Number: C111
• Device Catalogue Number: 04777433001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR