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

Lot Number 4090431

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2018, the lay user/patient¿s grandmother contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ping meter was reading inaccurately high compared to a laboratory device.The complaint was classified based on information obtained from the customer service representative (csr) documentation since the reporter could not be reached to obtain additional information.The reporter stated that the alleged inaccuracy issue began at 7:45 p.M., on (b)(6) 2018.The reporter claimed that the patient obtained blood glucose readings of ¿366 mg/dl¿ with the subject meter and ¿202 mg/dl¿ on the laboratory device, performed within 10 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results exceeds lfs¿ criteria for accuracy.The patient is (b)(6) and manages her diabetes with insulin pump therapy and the reporter advised that the patient exercised in response to the alleged elevated readings obtained on the subject device.The reporter denied that the patient developed symptoms as a result of the alleged issue.The reporter stated that on (b)(6) 2018, at around 10 p.M., the patient was taken to the emergency room (er) where she was admitted to hospital and treated with iv fluids by a health care professional (hcp).It is not known how long the patient remained in hospital.The patient¿s blood glucose was reportedly measured at ¿202 mg/dl¿ on the er/hospital device at 8:45 a.M., on (b)(6) 2018.At the time of troubleshooting, the csr established that the unit of measure was set correctly on the subject device at the time of testing, that an approved sample site was used to obtain the results and that the patient was following the correct testing procedure.The csr confirmed that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.Replacement products were sent to the patient.Although the patient developed signs suggestive of a serious injury adverse event, there is no indication that the subject meter caused or contributed to this injury.The reported hcp treatment was consistent with the alleged elevated reading obtained with the lfs device.However, this complaint is being reported as a malfunction since the alleged inaccuracy issue was not resolved with troubleshooting.

• Brand Name: OT PING 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 Key: 7446036
• MDR Text Key: 106848674
• Report Number: 3008382007-2018-01183
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 03/30/2018

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
• Device Operator: Lay User/Patient
• Device Lot Number: 4090431
• Other Device ID Number: 1-NQGOP7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/30/2018
• Device Age: 51 MO
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2014
• 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 Age: 9 YR
• Patient Weight: 37