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

Lot Number 4070311

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Nausea (1970); Anxiety (2328); Polydipsia (2604)

Event Type  Injury  

Event Description

On (b)(6) 2017, the patient contacted lifescan (lfs) usa alleging that her onetouch ping meter was reading inaccurately high.The complaint was classified based on customer service representative (csr) documentation, and further information clarified when medical surveillance specialist reviewed the call.The patient stated that the she became aware of the alleged product issue on (b)(6) 2017, around 2.21 am.The patient stated that she obtained inaccurately high blood glucose results of ¿217, 319, 281 mg/dl¿.The tests were performed within 20 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for precision.The patient manages her diabetes with insulin pump therapy, and made no changes to her normal diabetes management regimen, in response to the alleged meter issue.The patient reported that on (b)(6) 2017 at 1am, she developed symptoms of ¿extremely anxious, nervous, extreme thirst and nauseous¿.In response to the symptoms she took a blood glucose test and obtained a result of ¿419 mg/dl¿, which she felt was accurate.At 1.10 am she did not feel any better and administered a further 13 units of novolog.The patient is reporting that because of the inaccurate erratic readings, she is unsure how much insulin to administer, and has to suffer the alleged symptoms longer than normal.There is no evidence the patient received or required any treatment.At the time of troubleshooting, the cca confirmed the subject meter was set to the correct unit of measure and the control solution test had not been selected manually on the device, and the vial was not cracked or broken.The test strips were stored correctly and had not expired, and the patient was using an approved sample site.Csr noted the patient had no control solution.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while using the product.Although the patient¿s symptoms occurred prior them obtaining the alleged inaccurate results, the alleged meter issue could not be ruled out as a cause or contributor to the event.

• 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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7069976
• MDR Text Key: 93287345
• Report Number: 3008382007-2017-23417
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4070311
• 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: 11/28/2017
• Device Age: 52 MO
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2013
• 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): Life Threatening
• Patient Age: 33 YR
• Patient Weight: 91