MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CREATININE PLUS VER.2 ASSAY; ENZYMATIC METHOD, CREATININE

Catalog Number	03263991190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable assay results from multiple patient samples tested on the cobas 6000 c 501 (ul) v.The reporter provided examples of questionable aspartate aminotransferase acc.To ifcc without pyridoxal phosphate activation (astl) and crep gen.2 (crep2) results.This medwatch is for the creatinine plus ver.2 assay please refer to the medwatch with a1.Patient identifier (b)(6) for the aspartate aminotransferase assay.The initial result from the analyzer was 0.23 ng/ml.The repeat result from another analyzer was 1.49 mg/dl.The repeat result was deemed correct.The initial result was reported outside of the laboratory.The patient sample was rerun because of multiple invalidating flags for other assays.The reporter said they accidentally ran a whole blood patient sample for a complete metabolic panel (cmp) assay before the reported patient sample was run.
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c501 (ul)(b)(6).The field service engineer (fse) inspected the module and determined the incorrect specimen (whole blood) processed for the previous assays had caused the event.The fse cleaned the probe and verified the module's performance by multiple mechanism checks.The investigation is ongoing.

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• Common Device Name: ENZYMATIC METHOD, 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: 20482587
• Report Number: 1823260-2024-03014
• Device Sequence Number: 4096124
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K024098
• 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
• Report Date (Section B): 10/18/2024

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: 03263991190
• Device Lot Number: 801549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/18/2024
• 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