FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MULTICLIX
MDR report key: 1813065
·
Received August 24, 2010
Report
- Report Number
- 1823260-2010-05041
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- August 5, 2010
- Report Date
- September 2, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO FIRE DEVICE DUE TO A DEFECTIVE BUTTON. COULD NOT TEST TO SEE IF THE LANCET RETRACTED.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
REPORTER ALLEGED THE NEEDLE FROM THE MULTICLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.
Description of Event or Problem · 1
ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THE INOMAX DS (B)(4) DEVICE WAS MAKING A HISSING NOISE. THE DEVICE WAS NOT ON A PATIENT AND NO ADVERSE EVENT WAS REPORTED BY THE RESPIRATORY THERAPIST. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO THE COMPANY FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® MULTICLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | GWW017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |