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 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested with crep2 creatinine plus ver.2 on a cobas 8000 c 702 module.The results did not correspond to the clinical picture of the patient.The sample was initially tested on another c 702 analyzer, resulting with a crep2 value of -4 umol/l.The sample was repeated on the complained c 702 analyzer, resulting with a value of 2 umol/l.The sample was repeated on the complained c 702 analyzer, resulting as 3 umol/l.The results were reported to the doctor who did not believe the results fit the patient's clinical picture.The patient normally has crep2 values of 35 to 45 umol/l.No adverse events were alleged to have occurred with the patient.The c 702 analyzer serial number is (b)(4).

Manufacturer Narrative

The investigation found the results are consistent with acetaminophen/paracetamol intoxication.According to product labeling for the assay: acetaminophen intoxications are frequently treated with n-acetylcysteine.N-acetylcysteine at a plasma concentration above 333 mg/l and the acetaminophen metabolite n-acetyl-p-benzoquinone imine (napqi) independently may cause falsely low results.

• 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: 7915337
• MDR Text Key: 122012472
• Report Number: 1823260-2018-03310
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168589190
• Device Lot Number: 35181201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARIPIPRAZOLE (ANTIPSYCHOTICS); BENZODIAZEPINES; CANNABIS; CHEMADRIN (ANTIPARKINSON); METHADONE; OPIOIDS; PARACETAMOL; PREGABLIN (ANTIEPILEPSY / PAIN)
• Patient Age: 46 YR