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

Catalog Number	07027559190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).The expiration date was july 2018.(b)(6).
Event or Problem Description
The customer stated that they received erroneous results for two samples from the same patient tested with elecsys insulin on a cobas 8000 e 801 module.It was asked, but it is not known if the erroneous results were reported outside of the laboratory.The first sample initially resulted with an insulin value of 53.2 uu/ml when tested on the e 801 analyzer.The sample was repeated on the e 801 analyzer on (b)(4) 2018, resulting with an insulin value of 49.9 uu/ml.The second sample resulted with an insulin value of 49.6 uu/ml when tested on the e 801 analyzer.The samples were sent to other laboratories for testing on siemens centaur analyzers, resulting with values of 7.8 uu/ml and 7.6 uu/ml.It is not known which of the two samples each of the two repeat values correspond to.No adverse events were alleged to have occurred with the patient.The e 801 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
Calibration data was within expectations.Quality controls recovered within expectations on the day of the event.A general reagent issue can likely be excluded since quality controls were within expectations.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS INSULIN
• Common Device Name: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7897525
• Report Number: 1823260-2018-03225
• Device Sequence Number: 11189256
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 4015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 07027559190
• Device Lot Number: 269698
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 09/04/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/16/2018; 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR