MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-06 for ACCEAVA MONO TEST STRIP 25T (92404) IMO-411 manufactured by Alere San Diego, Inc..
[178128133]
Intake unable to speak with customer directly. Kit not being returned. Results pending investigation.
Patient Sequence No: 1, Text Type: N, H10
[178128134]
Unspecified date: customer reports the glass capillary tubes provided in the acceava mono ii test kit frequently break when attempting to collect the sample from the patient. No further information available. Intake was unable to speak to the customer directly; issue was reported by an abbott representative. No known impact to the operator or patient. Although no death or serious injury was reported at intake, as the capillary tube is glass and contains patient specimen, there is the potential for harm if the issue were to recur. Therefore, this mdr is being conservatively filed. Although further information was requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2020-00011 |
| MDR Report Key | 9679340 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-11 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | ACCEAVA MONO TEST STRIP 25T (92404) |
| Generic Name | MONONUCLEOSIS RAPID TEST |
| Product Code | KTN |
| Date Received | 2020-02-06 |
| Model Number | IMO-411 |
| Lot Number | NOT PROVIDED |
| 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 | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |