MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-25 for ICON 25HCG (COMBO CASSETTE) FHC202 manufactured by Alere San Diego Inc.
[22267703]
Caller alleging receiving a false negative on icon 25 hcg, one lot/pt, urine sample. The customer states that she had icon 25 pregnancy test that was performed on a pt going into surgery and was negative. The customer states that it was found that the pt was 12 weeks pregnant with twins after the surgery was performed. It is unk what surgery was performed. On follow-up, the customer stated that the surgery had no negative affect to the pt/pregnancy. No report of adverse pt sequela. No additional info provided.
Patient Sequence No: 1, Text Type: D, B5
[22344422]
Customer's observation was not replicated in-house with retention devices. Retention devices were tested with 3 high level hcg urine controls. All results were positive at read time. No false negatives were obtained. Pt was 12 weeks pregnant and may have had very high levels of hcg. Hook effective cannot be ruled out as a cause for the false negative. Manufacturing batch record review did not uncover any abnormalities. Root cause could not be determined without pt specimen in-house analysis. Product deficiency was not established. As there is no indication of a product deficiency, no corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-01043 |
| MDR Report Key | 4293949 |
| Report Source | 05 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-10-31 |
| Date of Event | 2014-10-31 |
| Date Mfgr Received | 2014-10-31 |
| Date Added to Maude | 2014-12-08 |
| 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 25HCG (COMBO CASSETTE) |
| Generic Name | HCG PREGNANCY |
| Product Code | DKZ |
| Date Received | 2014-11-25 |
| Model Number | FHC202 |
| Lot Number | HCG4040017 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-11-25 |