MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-09-07 for CLEARBLUE PLUS PREGNANCY TEST manufactured by Spd Swiss Precision Diagnostics Gmbh.
[54060267]
The user did not provide us with faulty device as well as with anymore details such us dates of the testing, miscarriage etc. The user called us again and said that she did not have regular periods and did not know when her period is due, so might have conducted the test at the wrong time. Further conversation with the product specialist revealed that user did not read instruction for use carefully and could not confirm that she had read the results correctly. A false negative has not been established as cause of the incident. Corrective action is not required as the root cause of the incident was not established. (b)(4). As the incident happened in (b)(6) we sent manufacturer's incident report to (b)(6) on 13 of may 2016 and final decision from the agency was to not investigate the incident.
Patient Sequence No: 1, Text Type: N, H10
[54060268]
User called and stated that she had used clearblue plus pregnancy test and had negative result some time ago. Based on the result she carried out on drinking. After few days she did another pregnancy test and got positive result. Later in hospital she was confirmed to be (b)(6) pregnant and had miscarriage. The user mentioned that test window turned yellow, which may suggest oversampling. However it was impossible to confirm oversampling as the test was discarded straight away by the user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006635320-2016-00001 |
| MDR Report Key | 5932486 |
| Report Source | CONSUMER |
| Date Received | 2016-09-07 |
| Date of Report | 2016-05-07 |
| Date Added to Maude | 2016-09-07 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH JOHNSON |
| Manufacturer Street | PRIORY BUSINESS PARK STANNARD WAY |
| Manufacturer City | BEDFORD, BEDFORDSHIRE MK443UP |
| Manufacturer Country | UK |
| Manufacturer Postal | MK44 3UP |
| Manufacturer Phone | 234835486 |
| Manufacturer G1 | ALERE (SHANGHAI) DIAGNOSTICS CO. LTD |
| Manufacturer Street | 15/F BLOCK B 36 AU PUI WAN STREET |
| Manufacturer City | FOTAN, HONG KONG |
| Manufacturer Country | CI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARBLUE PLUS PREGNANCY TEST |
| Generic Name | OVER THE COUNTER HCG PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2016-09-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Manufacturer Address | 47 ROUTE DE ST GEORGES PETIT-LANCY GENEVA, CH-1213 SZ CH-1213 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 2016-09-07 |