FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3893448
·
Received June 25, 2014
Report
- Report Number
- 1823260-2014-04638
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- March 30, 2014
- Report Date
- August 6, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS IN THE HIGH 200 MG/DL RANGE. CALLER ALLEGES THE ELEVATED READINGS ARE DUE TO THE PUMP NOT DELIVERING INSULIN PROPERLY. CALLER STATED HE IS HAVING TO DOUBLE HIS INSULIN. CALLER REPORTED HE CHANGED THE ACCESSORIES SEVERAL TIMES. CALLER STATED HE HAS BEEN ABLE TO SELF-TREAT AND HAS NOT NEEDED ANY OUTSIDE ASSISTANCE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP, CARTRIDGE, AND INFUSION SET FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371691 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |