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

Catalog Number 05168589190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for crep2 creatinine plus ver.2 on the cobas 8000 c 702 module.The sample initially resulted with a crep2 value of 1.47 mg/dl, which was reported outside of the laboratory.The sample was repeated on (b)(6) 2018 and it resulted as 1.72 mg/dl.The sample was repeated on an i-stat analyzer using a biosensor manufactured by abbott resulting as 5.4 mg/dl.The 5.4 mg/dl value was reported outside of the laboratory to the doctor.No adverse events were alleged to have occurred with the patient.The patient's status is good.The serial number of the c 702 analyzer is (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7808842
• MDR Text Key: 118103243
• Report Number: 1823260-2018-02831
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 4015630924998
• Combination Product (y/n): N
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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 Expiration Date: 01/31/2019
• Device Catalogue Number: 05168589190
• Device Lot Number: 33362401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEPHAZOLIN; LEVOPHED; METRONIDAZOLE
• Patient Age: 79 YR