MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-02-24 for MULTI DRUG 6 PANEL CUP 4016600131 manufactured by Abon Biopharm (hangzhou) Co., Ltd.
[5519961]
Caller alleged false positive cocaine results. Results as follows: client states that the icup device had one false presumptive positive result for coc on donor urine specimen. The client states that no line appeared in the testing region for coc at the five minute read time. The donor then was sent to another facility to produce a saliva specimen; result was negative. The saliva was sent to a lab for confirmation and the result was also negative. The type of device used for the saliva test is unknown. No adverse consequences to the patient based on the false positive coc results. Donor specimen was not available for further testing.
Patient Sequence No: 1, Text Type: D, B5
[12794287]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[33963023]
Investigation: customer's observation was not replicated in-house with retention and return devices. Retention (n=29) and return (n=7) products were tested with in-house drug free donor urine, all coc results were negative at read time. No coc false positive results were obtained. Manufacturing batch record review did not uncover any abnormalities. Root cause could not be determined from the information provided. Based on the information available, there is no indication of a product deficiency. No corrective action is required at this time. This issue will be subject to tracking and trending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2015-00137 |
| MDR Report Key | 4542728 |
| Report Source | 05,08 |
| Date Received | 2015-02-24 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-30 |
| Date Mfgr Received | 2015-03-02 |
| Date Added to Maude | 2015-03-30 |
| 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 | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Manufacturer G1 | ABON BIOPHARM (HANGZHOU) CO., LTD |
| Manufacturer Street | #198 12TH STREET EAST HANGZHOU ECON & TECH DEV AREA |
| Manufacturer City | HANGZHOU, ZHEJIANG ZHEJIANG 310018 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 310018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI DRUG 6 PANEL CUP |
| Generic Name | DRUGS OF ABUSE |
| Product Code | LDJ |
| Date Received | 2015-02-24 |
| Returned To Mfg | 2015-02-19 |
| Model Number | 4016600131 |
| Lot Number | DOA4070682 |
| Device Expiration Date | 2016-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABON BIOPHARM (HANGZHOU) CO., LTD |
| Manufacturer Address | #198 12TH STREET EAST HANGZHOU ECON & TECH DEV AREA HANGZHOU, ZHEJIANG ZHEJIANG 310018 CH 310018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-24 |