MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-24 for CLINITEK STATUS ANALYZER CT STATUS manufactured by Siemens Medical Solutions Diagnostics, Ltd..
[2122778]
Customer reported two false negative hcg result on the same patient sample on two different clinitek status instruments using lot 028619 reagent. Result was reported to the physician. Pregnancy was subsequently confirmed using ultrasound. The patient's treatment was not affected by the urine test result. No treatment was provided or denied prior to the ultrasound test.
Patient Sequence No: 1, Text Type: D, B5
[9244407]
Manufacturer was unable to confirm false negative results using lot 028619. Customer states that quality control is performed daily on instruments and customer is currently using the instruments.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2011-00018 |
| MDR Report Key | 2176027 |
| Report Source | 07 |
| Date Received | 2011-06-24 |
| Date of Report | 2011-05-27 |
| Date of Event | 2011-05-27 |
| Date Mfgr Received | 2011-05-27 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2011-12-23 |
| 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 | 7812693158 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD |
| 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 | CLINITEK STATUS ANALYZER |
| Product Code | LCX |
| Date Received | 2011-06-24 |
| Model Number | CT STATUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. |
| Manufacturer Address | NORTHERN ROAD SUDBURY, SUFFOLK CO106DX UK CO10 6DX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-24 |