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

Catalog Number	08057532190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable crej2 creatinine jaffé gen.2 result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.The floor nurse deemed the result critical prompting the rerun of the patient sample.The patient sample was rerun on the analyzer and two other modules: module a and module b.On (b)(6) 2023.The initial result from the analyzer was 4.49 mg/dl.The first repeat result from module a was 0.724 mg/dl.This repeat result was deemed correct.The second repeat result from module b was 0.766 mg/dl.On (b)(5).The third repeat result from the analyzer was 0.745 mg/dl.The fourth repeat result from the analyzer was 0.754 mg/dl.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2023 to (b)(6) 2023; the results were within specifications.The investigation reviewed the qc data, the ranges and standard deviations (sd) were not provided.The investigation was not able to evaluate the qc.The investigation reviewed the customer's handling of patient samples.The patient sample was centrifuged for 6.5 minutes.The investigation determined that the centrifugation time appears to be too short.The event was reviewed and the customer stated the event was specific to the reported patient sample.On the field service engineer's (fse) initial service visit, he inspected the analyzer and verified the gear pump (gp) pressure.He performed a 21-cup precision check with successful results.The customer performed qcs with acceptable results.On the fse's follow-up visit, he inspected the pipettors, rinse mechanism and tubings, and the reaction disk; and replaced the sample probe as a proactive measure.The customer performed qcs with acceptable results.The investigation determined the customer's actions (rerunning the patient sample) resolved the issue.

• Brand Name: CREATININE JAFFE GEN.2
• Common Device Name: CREATININE, ALKALINE PICRATE COLORIMETRY
• 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 46250-0457
• MDR Report Key: 18424437
• Report Number: 1823260-2024-00002
• Device Sequence Number: 7697188
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08057532190
• Device Lot Number: 7476620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/24/2024
• 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: 41 YR
• Patient Sex: Male