MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-08-15 for ICON 25HG (COMBO CASSETTE) FHC202 manufactured by Alere San Diego, Inc..
[4724507]
Caller alleging receiving a false negative on icon 25 hcg, one lot/patient, urine sample vs a positive on serum quant. Full detailed description: on (b)(6) 2014, a patient came in to physician's office to have iud placement. The physician did a urine pregnancy test, and the result came out negative. Customer stated that control line was good and that they waited a full 3 minute-read time and they had a second person verify the result. No retest was done on this test at that time. About 4 weeks later, patient complaint of discomfort. A quantitative serum test was done an the result came out positive (+) at 163,00 miu/ml, which, according to the customer, is equivalent to about 8 weeks. The lot number of the icon 25 used is l/n (b)(4), exp'n date: (b)(4) 2015. No patient sample was saved because their policy is to keep samples for only 48 hours. On (b)(4) 2014 customer reported that the physician removed the patient's iud and patient is fine. No patient information was provided. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[12276363]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00758 |
| MDR Report Key | 4036661 |
| Report Source | 05,08 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-06-19 |
| Date Mfgr Received | 2014-07-28 |
| Date Added to Maude | 2014-09-03 |
| 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 | ICON 25HG (COMBO CASSETTE) |
| Generic Name | HCG PREGNANCY |
| Product Code | DKZ |
| Date Received | 2014-08-15 |
| Model Number | FHC202 |
| Lot Number | HCG3100047 |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-08-15 |