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

Model Number CREAJ

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received photometer errors on their cobas 8000 c 702 module and multiple patient samples had high results for crej2 creatinine jaffe gen.2.The customer stated one patient sample received a sample clot error.The customer checked the probe and verified there was no clot or fibrin on the probe.The customer replaced the reagent and recalibrated.The customer then pulled patient samples for repeat testing and one patient sample had discrepant creatinine results.No incorrect results were reported outside of the laboratory.The sample initially resulted with a creatinine value of 2.08 mg/dl and repeated as 0.9 mg/dl.The repeat value was believed to be correct.The c 702 analyzer serial number is (b)(4).

Manufacturer Narrative

The field service engineer determined that water was no flowing properly in the analyzer.The gear pump and degasser were also ready for replacement.The gear pump and degasser were replaced.The customer ran calibration and controls.Normal operation was verified.The last calibration performed on (b)(6)2021 was ok and there were no alarms noted.Quality controls recovered within range, showing no indication of a reagent performance issue.Upon review of the alarm trace, there were multiple abnormal aspiration alarms, photometer alarms, sample clot detection alarms, and abnormal cell blank alarms occurring near the time the complained sample was processed.The investigation determined the service actions resolved the issue.

• Brand Name: CREJ2 CREATININE JAFFE GEN.2
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11317939
• MDR Text Key: 252093334
• Report Number: 1823260-2021-00434
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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 Model Number: CREAJ
• Device Catalogue Number: 06407137190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1