FDA Adverse Event
Injury
Summary report: N
ASSURE PRO TEST STRIP
MDR report key: 1013332
·
Received March 12, 2008
Report
- Report Number
- 1832816-2008-00011
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- February 29, 2008
- Report Date
- February 29, 2008
- Manufacturer
- PARLEX (EUROPE), LTD.
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION.
Description of Event or Problem · 1
CALLER INDICATED THAT THE ASSURE PRO METER WAS READING INACCURATELY. PATIENT BECAME DIAPHORETIC, CLAMMY AND COLD. CALLED 911. PARAMEDICS GOT A READING OF 400. THEY ARE NOT SURE WHAT TIME EXPIRED BETWEEN THE METER READING AND THE READING OF 400 WITH THE PARAMEDICS. NURSE'S REMEMBER SEEING AN ERROR MESSAGE OF E - SOMETHING, BUT THEY DO NOT KNOW WHICH ERROR MESSAGE NUMBER, ONLY 'E'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASSURE PRO TEST STRIP | BLOOD GLUCOSE TEST STRIP | NBW | PARLEX (EUROPE), LTD. | 460050 | 11027A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |