MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-07 for CLINITEK 500 ANALYZER 10311540 manufactured by Siemens Healthcare Diagnostics.
[17263364]
Customer reported approximately 30% of patient results are coming back as a red or brown color on their instrument. Color is reported by the instrument and all samples are normal yellow color by visual inspection. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[17502993]
The cause for the red or brown color on their instrument is unknown.
Patient Sequence No: 1, Text Type: N, H10
[32993818]
Customer indicated after reviewing technique and cleaning instrument resolved this issue. Instrument is fully operational. This data was reviewed with siemens medical affairs with following conclusion: abnormal color of urine requires further evidence of a pathologic state. Since the results are not affected the color does not instigate further investigation. Because this additional information was not available for the initial filed mdr, the mdr 1217157-2014-00066 was filed. Had this additional information been available, this event would have been assessed as not require filing mdr as per 21 cfr 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00066 |
| MDR Report Key | 3796806 |
| Report Source | 05,07 |
| Date Received | 2014-05-07 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-04-05 |
| Date Mfgr Received | 2014-05-07 |
| 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 | 0 |
| 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 | KIMBALL ELECTRONICS (WALES) LIMITED |
| Manufacturer Street | BRIDGEND INDUSTRIAL ESTATE WESTERN AVENUE |
| Manufacturer City | BRIDGEND, SOUTH WALES CF313TY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3TY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK 500 ANALYZER |
| Generic Name | CT 500 ANALYZER |
| Product Code | JIO |
| Date Received | 2014-05-07 |
| Catalog Number | 10311540 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-07 |