MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT FASTTAKE METER; GLUCOSE MONITORING SYS/KIT

Lot Number 2519794

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Headache (1880); Weakness (2145)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/ patient contacted lifescan (b)(4) alleging that her onetouch pocketscan (fasttake) meter was reading inaccurately high.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged product issue first started at an unspecified time ¿years ago¿ when the subject meter began reading inaccurately high.The patient reported obtaining the alleged inaccurate result of ¿hi¿ (greater than or equal to 33.3 mmol/l) compared to her feelings and/ or normal results and ¿hi¿ compared to the results of ¿4.9 mmol/l¿ and ¿3.2 mmol/l¿ obtained on another (mylife pura) meter.Neither meter to feelings/ normal results comparisons or meter to other meter comparisons meet the criteria necessary for lfs to determine the possibility of an inaccuracy.There can be no presumption as to which meter¿s reading is erroneous as the comparison was no made to a calibrated reference method.The patient did not provide information on her normal diabetes management routine and did not state if she took any action beyond her normal diabetes management routine in response to the alleged product issue.The patient reported that ¿shortly after¿ the start of the alleged product issue she developed the symptoms of ¿headache and felt weak¿ which she reported associating with an acute low blood glucose excursion.In response to these alleged symptoms, the patient reported that she was admitted to hospital where she received healthcare professional (hcp) treatment in the from of ¿glucose drip¿.The patient reported that before she left the hospital her blood glucose was tested on a hospital meter and the result obtained was ¿9.7 mmol/l¿.During troubleshooting the csr verified that the patient¿s test strips were expired at the time of the alleged product issue.Replacement products were not sent to the patient as the patient claimed to have ¿another meter¿ that she is comfortable with.This complaint is being reported because the patient reported receiving medical intervention for an acute blood low glucose excursion after obtaining alleged inaccurately high results with the subject meter.

• Brand Name: OT FASTTAKE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8840723
• MDR Text Key: 152625509
• Report Number: 3008382007-2019-03105
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K011479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/19/2019

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 Number: 2519794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 07/30/2019
• 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 Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR