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

Catalog Number	06407137190
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable crej2 creatinine jaffé gen.2 (crej2) result from one patient sample tested on the cobas 8000 c702 module.The initial result was reported to the patient.On (b)(6) 2024: the initial result from the module¿s line 2 was 1.54 mg/dl.On (b)(6) 2024: the repeat result from the module¿s line 4 was 1.76 mg/dl.This repeat result was deemed correct.On (b)(6) 2024: the repeat result from the module¿s line 2 was 2.01 mg/dl.
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The field service engineer performed a hardware check by test performance which failed.He then adjusted and checked the reagent probes, decontaminated the module, and replaced a sample probe.He again performed a hardware check by test performance rerun and the results were acceptable.The investigation reviewed the second repeat result's reaction monitor.A steep rise in absorbance was noted.The investigation reviewed the calibration data for line 1.The calibration from (b)(6) 2024 was within specifications.The investigation reviewed line 1's qc levels 1 and 2 recoveries from (b)(6) 2024.The recoveries were unstable with out of range results (-2 standard deviations).The qc for both levels was within range on the date of event.The investigation reviewed the alarm trace provided from (b)(6) 2024.The trace had multiple instrument/maintenance-related errors and pre-analytical related errors.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the event was consistent with a preanalytic issue (sample alarms in the alarm trace) at the customer site and a hardware performance issue (cell-rinse function).Preanalytics are within the customer's responsibility.The investigation determined the service actions resolved the issue.

• Brand Name: CREATININE JAFFÉ GEN. 2
• Common Device Name: 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: 19949353
• Report Number: 1823260-2024-02312
• Device Sequence Number: 8967278
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 06407137190
• Device Lot Number: 755381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown