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

Catalog Number 08057532190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 12/10/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 332427118
• Report Number: 1823260-2024-00002
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 08057532190
• Device Lot Number: 7476620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male