MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2013-09-06 for PCH PREGNANCY TEST FHC-P103P-ONC45 manufactured by Alere San Diego, Inc.
[3931171]
Caller reported potential false negative urine hcg test with pch pregnancy test. A consumer purchased pch pregnancy test for his wife on (b)(6) 2013. He stated the packaging was closed and his wife took the first test that day and a second test on (b)(6) 2013 using a urine cup. Both tests gave negative results. He said that his wife continued to fell sick so they purchased some cold medications, nyquil being one of them but still felt sick so they went to the doctor. The doctor confirmed that she was six weeks pregnant (date of testing and confirmation method not provided). This complaint initially reported to (b)(4) in (b)(6) but there was a delay in forwarding it to alere.
Patient Sequence No: 1, Text Type: D, B5
[11227795]
Retain testing: lot number (s) 2ev0588. Expiration date (s): 04/2014. Control lot: 25miu/ml hcg urine control lot: hcg130627-01. 100miu/ml hcg urine control lot: hcg130130-01. Summary of results: the retention devices meet qc specification. Details as below: correct positive results were observed when tested with 25miu/ml hcg urine control at 3 minute read time. (n=29). Corrective positive results were observed when tested with 100miu/ml hcg urine control at 3 minute read time. (n=5). All the c lines and minus lines appeared within 90 seconds meeting specifications for line intensity at the 3 minute read time. Conclusion: from retain testing with in-house controls, the client's result was not replicated, and the product performed as expected meeting qc specifications. Verified the product number, product description, lot number and batch record; no abnormal results were found. Summary of results: the return device meets qc specification. Details as below: correct positive results were observed when tested with 25miu/ml hcg urine control at 3 minutes read time. (n=1). The c line and minus line appeared within 90 seconds meeting specifications for line intensity at 3 minutes read time. Conclusion. From return testing with in-house control, the client's result was not replicated, and the product performed as expected. Customer's observation was nor replicated in-house with retention and returned devices. Retention devices were tested with cutoff hcg urine control (25miu/ml) and mid-level hcg urine control (100 miu/ml). All results were positive at read time. Customer only returned 1 device. Returned device was tested with ctoff hcg urine control and result was positive at read time. No false negatives were obtained. Mfg batch record review did not uncover any abnormalities. Root cause could not be determined without pt sample in-house analysis. Product deficiency was not established. This issue will be tracked and trended. No corrective action required at this time as no product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2013-00791 |
| MDR Report Key | 3373669 |
| Report Source | 04,08 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-08-13 |
| Date of Event | 2013-01-24 |
| Date Mfgr Received | 2013-08-13 |
| Date Added to Maude | 2013-09-30 |
| 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 |
| 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 RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCH PREGNANCY TEST |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2013-09-06 |
| Returned To Mfg | 2013-08-23 |
| Model Number | FHC-P103P-ONC45 |
| Lot Number | 2EV0588 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-06 |