MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for WONDFO manufactured by Guangzhou Wondfo Biotech Co., Ltd..
[56934380]
Patient Sequence No: 1, Text Type: N, H10
[56934381]
My company has received a letter from fda which forwarded us a report, mw5041883 that they received from a user through their medwatch program. The content of the report mw5041883 is as below: many fertility patients, include myself a physician used home pregnancy tests to check the beta-hcg in their systems. This can include following a hcg trigger injection or trying to determine if they are indeed pregnant. The company wondfo sells relatively inexpensive tests to consumers for quick, easy and supposedly accurate results. This test is labeled as having a sensitivity of 25miu/ml. I have had positive tests from this company all week long. Today i decided to get my hcg blood level checked and my results were 1. 76miu/ml. I have tested positive with the wondfo pregnancy test 3 times today at levels. My company carried out an investigation as soon as we received the letter. And our response to the event is as follows: the order of this product: order number:(b)(4). Order amount: (b)(4), product name: hcg urine strip, lot no. : w00130943-4, production date: 09/15/2013, expiry date: 09/15/2015. Investigation. Inspection of reserved samples: inspected the negative reference (lh, fsh, tsh) and the result was negative. Randomly inspected 22 urine samples, no positive result showed. Inspected the hcg standard with the concentration of 25miu/ml and 3miu/ml, the results were positive. Conclusion: there is no abnormal result with the reserved samples, and the inspection of the hcg standard with the concentration of 3miu/ml shows positive result, which is inconsistent with the reporter's result. Review of process inspection of the product there were two matching plans, 1130909 and 1130716, adopted in this batch of product. The matching plan 1130909 was inspected qualified on sep. 12th, 2013. Furthermore, the (b)(6) pieces of pads which used this plan were inspected by the inspectors, and no abnormal results were found. The lot number of the membrane of this plan is 130628, whose inspection result is qualified. The intermediate products and finished products which used this plan in the orders of (b)(6) clients were proved to be qualified. The matching plan 1130716 was inspected qualified on jul. 7th, 2013. Furthermore, the (b)(4) pieces of pads which used this plan were inspected by the inspectors, and no abnormal results were found. The lot number of the membrane of this plan is 130704, whose inspection result is qualified. The intermediate products and finished products which used this plan in the orders of (b)(6) clients were proved to be qualified. Conclusion: no abnormal result occured in the process inspection of the products. Possible reasons of false positive. Hcg concentration can be influenced by factors besides pregnancy, such as trophoblastic disease and some tumor diseases. The medical procedure containing hcg, like fertility treatment, may cause false positive. Chemical property of the urine sample changes, such as low ph and red blood cells remained. Conclusion: 2. 3. 1 and 2. 3. 2 are stated in the insert, while the 2. 3. 3 needs the consumer's assistance. Reason analysis: as for hcg urine test, the factors which cause false positive are: change of chemical property of urine, such as low ph (less than 4), red blood cells remained, positive nitrite and positive ketone body. Having overmuch meat (excessive intake of protein), vitamin c (more than 20mg/dl) and gout can increase the risk of false positive. Some hormone treatment, like clomiphene and gonadotrophin may cause false positive. We hope to communicate with the consumer more, know the details of the tests and the sources of samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004635103-2016-92801 |
| MDR Report Key | 5982985 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-28 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-06-23 |
| Device Manufacturer Date | 2013-09-15 |
| Date Added to Maude | 2016-09-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. YINGHONG WU |
| Manufacturer Street | NO.8 LIZHISHAN ROAD SCIENCE CITY |
| Manufacturer City | GUANGZHOU, GUANGDONG 510000 |
| Manufacturer Country | CH |
| Manufacturer Postal | 510000 |
| Manufacturer Phone | 0203229999 |
| Manufacturer G1 | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Manufacturer Street | NO.8 LIZHISHAN ROAD SCIENCE CITY |
| Manufacturer City | GUANGZHOU, GUANGDONG 510000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 510000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WONDFO |
| Generic Name | HCG URINE STRIP |
| Product Code | LCX |
| Date Received | 2016-09-28 |
| Lot Number | W00130943-4 |
| Device Expiration Date | 2015-09-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Manufacturer Address | NO.8 LIZHISHAN ROAD SCIENCE CITY, LUOGANG DISTRICT GUANGZHOU, GUANGDONG 510000 CH 510000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-28 |