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

Model Number CREP G2

Device Problems High Test Results (2457); Insufficient Information (3190)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The last calibration was performed on (b)(6) 2021.Calibration and qc were within specification.The alarm trace and pre-analytical sample handling details were requested, but not provided.The field service representative verified alignments and made adjustments, inspected probes and seals, and performed a precision test for creatinine with results within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable creatinine plus ver.2 results for one (1) patient sample on a cobas 8000 c701 module, serial number (b)(4).The initial result was 3.67 mg/dl.Reagent lot number 53373401 was used to obtain the result.The initial result was reported to the patient's provider, who ordered additional blood tests and a new sample was drawn.The result from the new sample was (b)(6) so the initial sample was retested.A numerical value for the result from the second sample was not provided.The repeat result from the initial sample was 0.78 mg/dl and was obtained on a different c701 analyzer.This result was deemed correct.The reagent lot number and expiration date that was used to obtain the result is unknown.The initial sample was repeated again and the result was 0.87 mg/dl.This result was obtained on the same analyzer that was used to obtain the initial result.Reagent lot number 53663901 with an expiration date of 30-nov-2021 was used to obtain the result of 0.87 mg/dl.

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11885096
• MDR Text Key: 252791705
• Report Number: 1823260-2021-01569
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 53373401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2021
• 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: 36 YR