FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 3200041
·
Received July 1, 2013
Report
- Report Number
- 1823260-2013-03969
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- June 5, 2013
- Report Date
- August 9, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS COMPACT PLUS SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS COMPACT PLUS SYSTEM 2. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN STRIPS WERE MISHANDLED BY THE INVESTIGATIVE UNIT.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH (B)(6) IS COMPACT PLUS SYSTEM 1, MEDWATCH WITH (B)(6) IS COMPACT PLUS SYSTEM 2.
Description of Event or Problem · 1
CALLER REPORTED BLOOD GLUCOSE RESULTS OF 103 MG/DL ON COMPACT PLUS SYSTEM 1, 206 MG/DL ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297948 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 20735145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 066 YR | MECHANICAL HEART VALVE| ASPIRIN| GLIPIZIDE| CARVEDILOL| PRAVACHOL| COUMADIN| SYNTHROID| PROTONIX| POTASSIUM CHLORIDE| COZAAR| HUMALOG| HUMULIN R| LEVEMIR| LASIX| PACEMAKER| SLEEP APNEA MACHINE |