FDA Adverse Event
Malfunction
Summary report: N
HGB PRO METER, BOXED
MDR report key: 1707167
·
Received May 26, 2010
Report
- Report Number
- 2248721-2010-00090
- Event Type
- Malfunction
- Date Received
- May 26, 2010
- Date of Event
- August 12, 2009
- Report Date
- May 26, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COMPLAINT ASSESSED TO BE REPORTABLE.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS: ITC HGB PRO READING HIGHER SIGNIFICANTLY THAN LAB RESULT. ON (B)(6) 2009, HGB PRO INSTRUMENT GAVE HEMOGLOBIN RESULT 14.1 VS UNK AUTOMATED CHEMISTRY ANALYZER 11.5 RESULT. CUSTOMER STATED "...THE MACHINE HAS READ HGB READINGS ALMOST TO 17.1". NO ADVERSE EVENT REPORTED. EVENT OCCURRED OUTSIDE THE UNITED SATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HGB PRO METER, BOXED | GKR | INTERNATIONAL TECHNIDYNE CORP. | HGB PRO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |