MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-06 for CLINITEK STATUS+ ANALYZER 10379675 manufactured by Siemens Healthcare Diagnotics.
[4386539]
Customer reported two false negative leukocyte results on instrument, whereas reference lab results were positive. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11783923]
The cause for discordant leukocyte results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[34966879]
Visual exam by tech operations of returned instrument showed no obvious damage or undue wear. Test with status check cassette indicated normal unit functionality. Performance test of returned & comparison instrument with multistix 10sg reagent done with test solutions contrived to 5 & 10 wbc/mcl. N=12 reps each test solution, each instrument. Both returned & comparison instrument gave similar results. All strips tested at 10 wbc/mcl reported as positive, as did majority tested at 5 wbc/mcl. Instrument results agreed with visual observation of tested strips. Customer did not return reagent used in original results. Customer observation of false negative leukocyte from clinitekstatus+ s/n (b)(4) using multistix 10sg reagent cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00063 |
| MDR Report Key | 3793883 |
| Report Source | 05,07 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-04-10 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-06-24 |
| 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 | MR. STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | NORTHERN RD |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS+ ANALYZER |
| Generic Name | CT STATUS+ ANALZER |
| Product Code | LJX |
| Date Received | 2014-05-06 |
| Catalog Number | 10379675 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOTICS |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-06 |