FDA Adverse Event
Malfunction
Summary report: N
SOFTCLIX® PLUS LANCET DEVICE
MDR report key: 1822466
·
Received September 1, 2010
Report
- Report Number
- 1823260-2010-05178
- Event Type
- Malfunction
- Date Received
- September 1, 2010
- Date of Event
- August 26, 2010
- Report Date
- September 23, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 57 MG/DL WITHIN 10 MINUTES. CUSTOMER HAD MADE A PEANUT BUTTER AND JELLO SANDWICH FOR HIS WIFE. WIFE FEELS HE MIGHT NOT HAVE CLEAN HIS HAND COMPLETELY AFTER MAKING HER THE SANDWICH. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Description of Event or Problem · 1
CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX PLUS DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTCLIX® PLUS LANCET DEVICE | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | BAW003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |