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

Lot Number 4309571

Device Problem Defective Component (2292)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging an issue with her onetouch ultra test strip vial.The patient claimed that the vial inside a sealed container was open.The complaint was classified based on further information obtained by the medical surveillance specialist after reviewing the call recording since the patient was unable to be contacted by phone for additional information.The patient reported that she became aware of the alleged open vial on (b)(6) 2018 at 8:00 am.The patient informed the csr that she manages her diabetes with a combination of oral medication (metformin) and insulin (humulin).The patient denied making any changes to her usual diabetes management regimen when she was unable to test her blood glucose due to the alleged issue.During the call, the patient reported developing ¿low blood sugar¿ as a result of the alleged issue.The patient claimed she proceeded to the urgent care clinic on (b)(6) 2018 at 10:00 am where her blood glucose was measured at ¿48 mg/dl¿ on the clinic device.During the call, the patient claimed she received unspecified treatment and was reportedly advised to increase her daily dose of metformin medication.At the time of troubleshooting, the customer service representative confirmed the product was being used for the first time.Replacement product was sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject device could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA TEST STRIPS
• 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: 7220952
• MDR Text Key: 98278120
• Report Number: 3008382007-2018-00304
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00353885009713
• UDI-Public: 00353885009713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043197
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4309571
• Other Device ID Number: 1-AV-1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2018
• Date Manufacturer Received: 01/17/2018
• 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 Number: 1
• Patient Outcome(s): Life Threatening