OT SELECT SIMPLE METER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-07-09 for OT SELECT SIMPLE METER manufactured by Lifescan Europe, A Division Of Cilag Gmbh Intl.

Event Text Entries

[113396231] On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) (b)(4) alleging that their onetouch select simple meter read inaccurately high compared to their feelings and/or normal results. The complaint was classified based on the customer service representative (csr) documentation. The patient stated that the alleged product issue occurred on an unspecified date about one week prior to the alert date of (b)(6) 2018. At this time, the patient obtained blood glucose results of? 5-6 mmol/l (? Fbs? ) and? 10-11 mmol/l? (? Rbs? ). Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine the possibility of inaccuracy. The patient manages their diabetes with sc actrapid insulin? 12 units before breakfast, 16 units before lunch and 14 units before dinner? As well as with sc insulatard? 18 units before bed. The patient did not make any changes to their usual diabetes management regimen at the time the alleged product issue occurred. The patient stated that 2 hours after dinner, about a week ago, they developed the symptoms of? Hand tremors and too weak and tired to move?. As a result of these symptoms the patient self-treated with food and drink. Subsequently, the patient also visited the hospital where they were admitted for observation. The patient had the same symptoms on (b)(6) while in hospital and while using the hospitals accu-check meter. Blood glucose results of? 5. 2-3. 8 mmol/l? And? 6. 8-3. 7 mmol/l? Were obtained on these days on this meter respectively. At the time of troubleshooting, the csr noted that the reporter was unable to walk through a control solution test. The unit of measure was set correctly. 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 inaccurately high results, the alleged meter issue could not be ruled out as a cause or contributor to the event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008382007-2018-01936
• MDR Report Key: 7669246
• Report Source: CONSUMER,FOREIGN
• Date Received: 2018-07-09
• Date of Report: 2018-07-04
• Date Facility Aware: 2018-07-04
• Date Mfgr Received: 2018-07-04
• Date Added to Maude: 2018-07-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER CAREGIVERS
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: M. CHIUSANO / Y. WANDOLSKI
• Manufacturer Street: GUBELSTRASSE 34
• Manufacturer City: ZUG 6300
• Manufacturer Country: SZ
• Manufacturer Postal: 6300
• Manufacturer G1: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
• Manufacturer Street: GUBELSTRASSE 34
• Manufacturer City: ZUG 6300
• Manufacturer Country: SZ
• Manufacturer Postal Code: 6300
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: OT SELECT SIMPLE METER
• Generic Name: GLUCOSE MONITORING SYS/KIT
• Product Code: NBW
• Date Received: 2018-07-09
• Lot Number: 4387185
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
• Manufacturer Address: GUBELSTRASSE 34 ZUG 6300 SZ 6300

Device Sequence Number: 1

• Brand Name: OT SELECT SIMPLE METER
• Generic Name: GLUCOSE MONITORING SYS/KIT
• Product Code: PYV
• Date Received: 2018-07-09
• Lot Number: 4387185
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
• Manufacturer Address: GUBELSTRASSE 34 ZUG 6300 SZ 6300

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2018-07-09