MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS C-PEPTIDE; C-PEPTIDES OF PROINSULIN TEST SYSTEM

Catalog Number 03184897190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Phone (b)(6).This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys c-peptide results for one patient tested on a cobas 8000 e 602 module serial number: (b)(4).The customer also performed testing on a siemens immulite 2000 analyzer to compare results and to detect any sample or reagent interferences.The questionable results were reported outside the laboratory.Refer to the attachment for all patient data.This medwatch is for elecsys c-peptide.Refer to medwatch with patient identifier: (b)(6) for the elecsys insulin assay.

Manufacturer Narrative

On (b)(6) 2020, the patient had a new sample collected.The customer performed elecsys insulin and elecsys c-peptide testing on a cobas 8000 e 602 module and a siemens immulite 2000 analyzer.The patient's results on the e 602 module were insulin 57.45 uu/ml, c-peptide 1.44 ng/ml, molar ratio insulin/c-peptide 0.83, and peg recovery 8%.The patient's results on the siemens immulite 2000 analyzer were insulin 55.6 mcu/ml, c-peptide 1.05 ng/ml, and molar ratio insulin/c-peptide 1.15.No questionable results were reported outside the laboratory and no adverse events occurred.

Manufacturer Narrative

Internal method comparison data confirm the tendency of higher recovery of the elecsys c-peptide compared to siemens immunlite c-peptide.It needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.Additionally, single measurements can statistically deviate and are not useful to demonstrate a general difference between methods.Further sample investigations were not possible based on the lack of remaining sample.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS C-PEPTIDE
• Type of Device: C-PEPTIDES OF PROINSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10515500
• MDR Text Key: 231226257
• Report Number: 1823260-2020-02232
• Device Sequence Number: 1
• Product Code: JKD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03184897190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR