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

Model Number CREAJ

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's pre-analytics were determined to be acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable crej2 creatinine jaffé gen.2 results for one patient tested on two cobas 8000 c 702 modules.The patient's initial creatinine result was 0.21 mg/dl, and the patient's repeat result was 0.92 mg/dl.It is unknown whether the initial result was reported outside the lab.This information was requested but not provided.The initial testing was on c 702 module serial number (b)(4).The c 702 module serial number for repeat testing was requested but not provided.

• 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
• 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: 10577123
• MDR Text Key: 208388996
• Report Number: 1823260-2020-02337
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

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: 480880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/23/2020
• 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: 90 YR