MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-04 for CLINITEK ATLAS manufactured by Sparton Medical Systems.
[2328727]
Customer reported a negative blood result from the instrument. Uf result for rbc was 30. Manual microscopic examination indicated many blood cells. No unnecessary medical procedure was performed. No treatment was withheld as a result of this incident. There was no impact to patient health.
Patient Sequence No: 1, Text Type: D, B5
[9457573]
Field service engineer dispatched. Instrument read head and lamp replaced. Instrument operating according to specification. The reason for the incorrect result is not known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00025 |
| MDR Report Key | 2245062 |
| Report Source | 07 |
| Date Received | 2011-08-04 |
| Date of Report | 2011-07-05 |
| Date of Event | 2011-07-05 |
| Date Mfgr Received | 2011-07-05 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2012-06-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7782693158 |
| Manufacturer G1 | SPARTON MEDICAL SYSTEMS |
| Manufacturer Street | 22740 LUNN ROAD |
| Manufacturer City | CLEVELAND OH 44149 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44149 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK ATLAS |
| Generic Name | CLINITEK ATLAS |
| Product Code | JHJ |
| Date Received | 2011-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPARTON MEDICAL SYSTEMS |
| Manufacturer Address | 22740 LUNN ROAD CLEVELAND OH 44149 US 44149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-04 |