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

Catalog Number 08057532190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable creaj2 (creatinine) results from the cobas pro c 503 analytical unit.Sample 1 initial result was 3.14 mg/dl and the repeat result was 0.84 mg/dl.Sample 2 initial result was 3.04 mg/dl and the repeat result was 0.77 mg/dl.The repeat results were believed correct.

Manufacturer Narrative

The analyzer serial number was (b)(6).The field service engineer checked the analyzer and could not find a cause.He checked all components, secured all fittings, and checked the external probe rinse levels, cuvette rinse levels, photometer absorbance, gear pump pressures, and probe alignments.He replaced the reagent and sample probes and performed alignments.He adjusted the gear pump and changed the incubation bath and bath circulation.He performed precision testing, hardware checks, calibration, and qc.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 18066640
• MDR Text Key: 327303431
• Report Number: 1823260-2023-03513
• 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
• Report Date: 11/03/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 08057532190
• Device Lot Number: 73634001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/03/2023
• 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: 40 YR
• Patient Sex: Male