MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	06407137190
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	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The last calibration was performed on 27-sep-2023 and it was acceptable.The customer uses a 3rd party qc.Qc was performed and it was within range.The alarm trace showed multiple alarms including abnormal sample aspiration, sample short, and abnormal aspiration.It also showed one more abnormal aspiration (sample probe b) alarm.A general reagent issue can be ruled out because calibration and qc data were acceptable.The centrifugation time was 7 minutes and it seemed to be short.Based on the provided data, the root cause is suspected to be related to a pre-analytical issue.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with creatinine (creaj2) assay on a cobas 8000 c702 analyzer.Initial result: 18 mol/l.On 27-sep-2023 the physician questioned the result and the sample was then repeated.1st rerun result: 123 mol/l 2nd rerun result: 111 mol/l 3rd rerun result: 121 mol/l.An amended report with the correct result of 121 mol/l was reported to the physician.
Additional Manufacturer Narrative
A general reagent issue can be excluded since calibration and qc data were acceptable.The alarm trace showed multiple alarms including abnormal sample aspiration, sample short, and abnormal aspiration alarms.An abnormal aspiration alarm was noted on the day of the event.The centrifugation time was 7 minutes which seemed short according to the tube manufacturer's recommendation.Based on the provided data and information, it was noticeable that there were abnormal aspiration alarms and centrifugation conditions that did not correspond with the tube manufacturer´s recommendations.The root cause was consistent with a pre-analytical issue.The customer was advised to follow the tube manufacturer's recommendation.The investigation did not identify a product problem.

• Brand Name: CREJ2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17988070
• Report Number: 1823260-2023-03392
• Device Sequence Number: 7259911
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K951595
• 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): 11/22/2023

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 Expiration Date: 11/30/2024
• Device Catalogue Number: 06407137190
• Device Lot Number: 70736001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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 Sex: Unknown