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Catalog Number 05060303001
Device Problem Display Difficult to Read (1181)
Patient Problem Death (1802)
Event Date 01/17/2016
Event Type  Death  
Manufacturer Narrative
This mdr is being filed based upon information documented in mdr (b)(4). Roche diagnostics did not receive a copy of this report but was notified of this event on (b)(6) 2016 by fda. There was no customer information provided that would allow requesting the return of the devices.
Event Description
A representative from the fda stated in an email on (b)(6) 2016 that "mdr ((b)(4)) came to our attention this morning. I have limited information, but apparently the staff interpreted the same error message (rrlo-out of range w-10, verify with venous collection) on 2 different informs as a glucose value and the patient was treated with insulin. " the fda provided roche a description of the event as follows: "as part of the patient's standard glucose monitoring protocol, an evening fingerstick was performed using point of care testing via the accuchek inform ii glucose meter. The initial results displayed a reading of `rrlo with a message w-150 out of reportable range, verify with venous collection'. A repeat test was done on another accuchek glucometer that displayed the same results. Staff interpreted the `w-510 out of reportable range' to be an actual glucose reading and reported 'these results' to the medical staff. The misinterpretation of the results in the patient led to the patient receiving additional insulin coverage. A review of the case and blood glucose management was undertaken and it was determined that the display message from the accuchek contributed to the staff misinterpretation of the results. It was further determined that the actual display from the accuchek inform ii blood glucose monitor may represent a design flaw in that it displays a numerical value associated with an out of reportable range message which would require further medical management. " on (b)(6) 2016 in another email the representative further stated that "i have received an update from the customer. They did not report to roche. The patient was treated with insulin for a presumed bg of 510. The incident did result in the patient's death. The patient was a dnr, but it was not clear from the report if the patient was considered "terminal" at the time of the event. " no patient symptoms at the time of the event are provided. There was no information provided as to the type of insulin, how much insulin or what route the insulin was delivered. There was also no information provided as to the time frame between the insulin delivered and the time of the patient's death. Since the customer name was not provided, any further details from the customer are not possible. Based upon the limited information provided, both meters appropriately alerted the user that the results were outside of the reportable range of the device, as noted by the w-510 alarm. There is no indication the meter malfunctioned. Based upon the information provided, the meter in this event was used in a professional setting. It is up to each individual facility to determine their specific procedures for handling results that are accompanied by alerts and warnings. It is expected the lab staff is trained on the interpretation of these alerts and warnings and their established procedures for handling and use of results with an alarm or warning. The date of the death as noted could not be confirmed. Without additional information and/or return of the meter in question, this event cannot be fully investigated.
Manufacturer Narrative
Product labeling (operator's manual) is provided to customers to describe how to interpret test results which are accompanied by an alert, such as rr lo/rr hi. These are built in safeguards to notify the user there may be a problem with the result. The pop up message displayed on the screen overlays the actual result screen and alerts the user of the issue. All warning messages are accompanied by a warning symbol, in this case a red exclamation point enclosed in a red triangle, which should further alert the user of the device to a potential issue with a test result. The screen would also have contained "rr lo" in large, bold letters, as well as "out of reportable range" enclosed in a blue box, and the text, "w-510: verify with venous collection. " both meters mentioned in the report appropriately alerted the user that the results were outside of the reportable range of the device, as noted by the w- 510 alarm. There is no indication the meter malfunctioned. Without additional information and/or return of the meter in question, the issue cannot be investigated further. Medical professionals must be trained in using medical devices. Critical decisions of medical treatment should be done only by qualified and trained professionals. Administration of insulin and the decision of indication and dosage may have serious consequences; therefore it is of utmost importance to confirm results, if it is requested by an alarm or flag, which was displayed in this case in addition to the warnings.
Manufacturer Narrative
The user facility provided new information related to this same event in a separate user facility report, (b)(4). The facility began a human factors evaluation on 03/01/2016 that is ongoing. The results of the study were not provided.
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Manufacturer (Section D)
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
sandhoferstrasse 116
mannheim (baden-wurttemberg) 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
indianapolis, IN 46250
MDR Report Key5541619
MDR Text Key41671473
Report Number1823260-2016-00396
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number05060303001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2016
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

Patient Treatment Data
Date Received: 04/01/2016 Patient Sequence Number: 1