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

Catalog Number 06407137190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas 8000 c702 module serial number was (b)(6).A general reagent problem was ruled out because calibration and quality control were acceptable.The investigation is ongoing.

Event Description

There was an allegation of a questionable creatinine jaffé gen.2 result from the cobas 8000 c702 module.The initial result was 14.74 mg/dl and the repeat result on another cobas analyzer was 6.49 mg/dl.The sample was repeated using ortho and the result was 7.90 mg/dl.

Manufacturer Narrative

The investigation did not identify a product problem.The specific cause of the event could not be determined.Based on the calibration data, the event is consistent with a high concentration of co2 in the ambient air of the laboratory.

• Brand Name: CREATININE JAFFÉ GEN. 2
• Type of Device: 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: 19171682
• MDR Text Key: 341374133
• Report Number: 1823260-2024-01256
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 06407137190
• Device Lot Number: 766134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female