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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT SELECT SIMPLE METER; GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT SELECT SIMPLE METER; GLUCOSE MONITORING SYS/KIT Back to Search Results
Lot Number 4420762
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Lethargy (2560)
Event Type  Injury  
Event Description
On (b)(6) 2018, the reporter contacted lifescan (lfs) (b)(4), alleging that the patient¿s onetouch select simple meter was reading inaccurately high compared to their feelings and/or normal results.The complaint was classified based on customer service representative (csr) documentation.The reporter stated that the meter issue began approximately 5 days prior to them contacting lfs, alleging that the patient obtained inaccurately high blood glucose results of ¿400, 450, 520 and 480 mg/dl¿ on the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The reporter stated that the patient manages their diabetes using insulin (self-adjuster) and in response to the alleged issue, they increased their normal insulin dose from 16 units to 35 units for 4 days.The reporter alleged that approximately 4 days after the issue began, the patient developed symptoms of ¿drowsy and sleepy¿.There is no evidence the patient required or received any treatment in response to the symptoms.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure and the patient did not have control solution.The csr also noted that the patient¿s test strips and control solution, had been stored correctly, were within expiry date.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms of a serious injury adverse, whilst using the product.There is insufficient information to rule out the contribution of the subject meter to the event.
 
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Brand Name
OT SELECT SIMPLE METER
Type of Device
GLUCOSE MONITORING SYS/KIT
Manufacturer (Section D)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug 6300
SZ  6300
Manufacturer (Section G)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug 6300
SZ   6300
Manufacturer Contact
mariano chiusano
gubelstrasse 34
zug 6300
SZ   6300
MDR Report Key8063266
MDR Text Key126922287
Report Number3008382007-2018-03121
Device Sequence Number1
Product Code PYV
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number4420762
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/31/2018
Initial Date Manufacturer Received 10/31/2018
Initial Date FDA Received11/13/2018
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 Initial
Patient Sequence Number1
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