MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-07 for CARDINAL HEALTH RAPID TEST HCG COMBO 30T FHC-A202 manufactured by Alere San Diego, Inc..
[188859229]
At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4). Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions. This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)). The awareness date is based on updated reporting decisions and completion of the retrospective review activity. There is no new or increased trend based on this retrospective review activity. Investigation conclusion: further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer did not provide a lot number. The root cause cannot be determined due to insufficient information. No corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[188859230]
Health hcg combo cassette rapid test in place of controls. There are no cardinal hcg serum controls available. There were weak positive results on serum samples known to be less than the level of detection (<10 miu/ml) for the cardinal health hcg combo cassette rapid test. No further information provided. The customer did not want to trouble shoot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00447 |
| MDR Report Key | 9559285 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date Mfgr Received | 2019-07-19 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MONIKA BURRELL |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL HEALTH RAPID TEST HCG COMBO 30T |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-01-07 |
| Model Number | FHC-A202 |
| Lot Number | NOT PROVIDED |
| 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 | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |