FDA Adverse Event
Malfunction
Summary report: N
H-TRONPLUS
MDR report key: 1003222
·
Received February 21, 2008
Report
- Report Number
- 2183996-2008-00188
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 22, 2008
- Report Date
- January 22, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K023471
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IN 2008, THE PATIENT REPORTED THAT HE RECEIVED THE 09 (TECHNICAL INSPECTION DUE) ALARM ON HIS INFUSION DEVICE. HE STATED THAT HE DID NOT RECEIVE ANY OF THE PRIOR 8X ALERTS (88, 86, 84, 82) WARNING HIM THAT THE INFUSION DEVICE WOULD SOON SHUT DOWN. THE PATIENT WAS AT WORK AND STATED THAT HE DID NOT HAVE HIS BACKUP INFUSION DEVICE WITH HIM. HE DISCONNECTED THE CALL WHEN HE WAS TOLD IT WAS NOT POSSIBLE TO PLACE THE INFUSION DEVICE BACK IN THE RUN MODE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | H-TRONPLUS | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION SET |