FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT
MDR report key: 3222407
·
Received July 12, 2013
Report
- Report Number
- 2183996-2013-01278
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- May 10, 2013
- Report Date
- September 25, 2013
- Manufacturer
- ROCHE HEALTH SOLUTIONS INC
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED.
Additional Manufacturer Narrative · 1
IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
ON (B)(6) 2013, PATIENT REPORTED THERE ARE SCRATCHES ON THE INFUSION DEVICE DISPLAY THAT INTERFERE WITH HIS ABILITY TO VIEW THE INSULIN DELIVERY AMOUNTS. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE, AND THERE ARE NO BLACK SPOTS ON THE DISPLAY. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323527 | ACCU-CHEK ® SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE HEALTH SOLUTIONS INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 074 YR | NOVOLOG INSULIN| FREEDOM LITE BLOOD SUGAR METER |