MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-21 for PSS CONSULT HCG URINE CASSETTE 4584655014 manufactured by Biosite Incorporated.
[1223140]
Caller reported false negative urine hcg result. No quantitative hcg result provided. The pregnancy was confirmed by ultrasound - (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[8284335]
Investigation: lot number(s): hcg9030207. Exp. Date(s): 03/2011. Control lot: 20miu/ml hcg urine, lot: hcg090304-01. 100miu/ml hcg urine, lot: hcg090521-01. 255. 3iu/ml hcg urine, lot: hcg090526-03. 500iu/ml hcg, lot: hcg090603-01. Summary of results: the retention devices meet qc specification. Correct positive results were observed when tested with 20miu/ml and 100miu/ml hcg urine control at 3 minutes read time. The high hcg samples (255. 3iu/ml hcg and 500iu/ml hcg) yielded clearly positive results at 3 minutes reading time. Conclusion: the retention devices meet qc specification. No abnormal result was observed; this complaint is not confirmed. Nothing abnormal found in batch review and the product number, product description and lot number was verified. No corrective action is required at this time as product deficiency was not established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2009-00849 |
| MDR Report Key | 1504037 |
| Report Source | 05,07 |
| Date Received | 2009-09-21 |
| Date of Report | 2009-09-21 |
| Date of Event | 2009-08-26 |
| Date Mfgr Received | 2009-08-26 |
| Date Added to Maude | 2009-12-16 |
| 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 | CARMEN BERGELIN, MGR. |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSS CONSULT HCG URINE CASSETTE |
| Generic Name | HCG PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2009-09-21 |
| Model Number | 4584655014 |
| Lot Number | HCG9030207 |
| Device Expiration Date | 2011-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INCORPORATED |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-21 |