MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2 CREATININE JAFFÉ GEN.2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	06407137190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable crej2 creatinine jaffé gen.2 control and patient results tested on a cobas 8000 c702 module.The customer stated that there is about a 25% difference in the initial patient and control results compared to when the same samples are retested.Specific patient results were requested but were not provided.The customer stated that this issue occurs sometimes when the reagent pack is almost empty.The results are again acceptable after performing a new calibration.The erroneous results were released outside of the laboratory, but no treatment was provided based on the erroneous results.There was no allegation of an adverse event.The cobas c702 serial number was (b)(4).A field engineering specialist changed the reagent probes, adjusted the reagent probes, and readjusted the cells.The customer stated they believed the carbon dioxide levels in the laboratory were acceptable.On (b)(6) 2018 the customer reported the issue was still ongoing.No specific details provided.The investigation is currently ongoing.
Additional Manufacturer Narrative
The customer has not reported any additional issues.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREJ2 CREATININE JAFFÉ GEN.2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7695280
• Report Number: 1823260-2018-02372
• Device Sequence Number: 13701919
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951595
• 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
• Report Date (Section B): 09/17/2018

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 Catalogue Number: 06407137190
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1