MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS INSULIN; IMMUNOREACTIVE INSULIN TEST SYSTEM

Catalog Number 12017547122

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys insulin (ins) on a cobas 6000 e 601 module (e601).The sample initially resulted as 1.05 uu/ml accompanied by a data flag on the e601 analyzer (reference range = 2.6 - 24.9 uu/ml).The initial value was reported outside of the laboratory.The sample was repeated on the e601 analyzer, resulting as 0.970 uu/ml accompanied by a data flag.On (b)(6) 2017, the sample was repeated on an abbott architect four times, resulting as follows: 227.7 uu/ml, 227 uu/ml, 218 uu/ml, and 228 uu/ml (reference range = 2.0 - 23.0 uu/ml).A sample collected at the same time as the original sample was tested on the e601 analyzer on (b)(6) 2017, resulting as 0.85 uu/ml.Two samples collected at the same time as the original sample were also repeated on the abbott architect analyzer on (b)(6) 2017, with each resulting as 223.9 uu/ml and 206.4 uu/ml.No adverse events were alleged to have occurred with the patient.The e601 analyzer serial number was asked for, but not provided.The customer does not run quality controls daily.

Manufacturer Narrative

Calibration signals were within expectations.The last calibration was performed outside of the recommended one month.Control recovery is within specified ranges, but no control data was available from the date of the event.The most likely root cause is that the roche assay does not measure insulin analogues, whereas, cross reactivity to insulin analogues is likely when measured with the abbott architect method.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• 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: 6600496
• MDR Text Key: 76420011
• Report Number: 1823260-2017-01110
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K001104
• 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,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12017547122
• Device Lot Number: 15780501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR