ONE TOUCH II

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-18 for ONE TOUCH II manufactured by Lifescan.

Event Text Entries

[2020] Bg for pt was 29 per one touch ii meter. Lab value was 367. Pt was treated for hypoglycemia & subsequently given insulin. No adverse effert on patient. Pt also being momtared by telemetry. Pt had hx of 3 days nausea, vomiting & was dehydrated. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, performance tests performed. Results of evaluation: none or unknown. Conclusion: device failure related to patient condition, device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3651
• MDR Report Key: 3651
• Date Received: 1992-08-18
• Date of Report: 1992-05-12
• Date of Event: 1992-04-08
• Date Facility Aware: 1992-04-08
• Report Date: 1992-05-12
• Date Reported to Mfgr: 1992-04-11
• Date Added to Maude: 1993-04-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ONE TOUCH II
• Generic Name: BLOOD GLUROSE METER
• Product Code: LHE
• Date Received: 1992-08-18
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Device Age: 01-MAR-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3397
• Manufacturer: LIFESCAN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-18