FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® COMPACT PLUS
MDR report key: 3230061
·
Received July 16, 2013
Report
- Report Number
- 1823260-2013-04280
- Event Type
- Injury
- Date Received
- July 16, 2013
- Date of Event
- June 13, 2013
- Report Date
- September 6, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHARMACIST
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 AN INCIDENT OF HYPOGLYCEMIA REQUIRING HOSPITALIZATION AT A TIME WHEN THE COMPACT PLUS SYSTEM WAS UNAVAILABLE FOR USE DUE TO NO POWER. HUSBAND STATED WIFE HAD A SEIZURE AT 11:30PM ON (B)(6) 2013. WHEN HE TRIED TEST WIFE'S BLOOD GLUCOSE AT 11:45PM, COMPACT PLUS METER HAD NO POWER. HE CALLED THE EMTS; THEY TESTED CUSTOMER BLOOD GLUCOSE AS 22 MG/DL. HUSBAND STATED EMTS GAVE WIFE TUBS OF GLUCOSE AND SOME SUGAR TO EAT. EMTS TOOK CUSTOMER TO THE HOSPITAL, WHERE SHE WAS ADMITTED UNTIL (B)(6) 2013. THE TIME FRAME BETWEEN HUSBAND ATTEMPTING USE METER AND GOING TO THE HOSPITAL WAS ABOUT 15 MINUTES. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328717 | ACCU-CHEK ® COMPACT PLUS | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 078 YR | Hospitalization | NOVOLOG 70/30| GLIPIZIDE 2 X A DAY| HUMULIN R| METFORMIN 2 X A DAY |