FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT COMBO
MDR report key: 2982062
·
Received February 8, 2013
Report
- Report Number
- 2183996-2013-00180
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- January 31, 2013
- Report Date
- March 26, 2013
- Manufacturer
- ROCHE HEALTH SOLUTIONS INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
THE COMPLAINT CANNOT BE VERIFIED; THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. NO MALFUNCTION OF THE PUMP WAS OBSERVED.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE SWITCHED OFF BY ITSELF, AND THE PT WOKE UP WITH A BLOOD GLUCOSE VALUE OF 350 MG/DL. HIS MOTHER WAS ABLE TO TREAT HIS BLOOD GLUCOSE BY HERSELF, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55373 | ACCU-CHEK SPIRIT COMBO | LZG | ROCHE HEALTH SOLUTIONS INC. | 00700006863 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP |