MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-04-14 for NONE manufactured by .
[20792143]
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Patient Sequence No: 1, Text Type: D, B5
[20966220]
A similar empty solvent vial incident was reported in (b)(6) 2010, prompting an fda inspection. Local fda officers visited amnisure (b)(4) and conducted a full quality system audit from (b)(6) 2010. During this audit, they evaluated the corrective action opened to investigate and resolve the recent increase in empty solvent vial complaints. It was brought to the officer's attention that while an empty solvent vial may render the disposable diagnostic test kit unusable, this does not affect patient safety or the clinical diagnosis. Corrective actions to solve the problem were discussed and fda officers agreed that amnisure was following through with these actions properly. Mr (b)(6) contacted amnisure about an empty solvent vial on (b)(6) 2011. His description of the incident is accurate. Mr (b)(6) was offered a replacement set of tests for the inconvenience and was informed of the manufacturing changes being put into effect. These changes include, but are not limited to, the adoption of an automated vial filling and capping process that employs a very specific torque, new caps and vials that allow for a tighter closure, and increased filled-vial inspection parameters. Amnisure did not submit a 3500a form because the "mdr for manufacturers" guidance document states that a report should only be filed in the event of a malfunction that may cause an adverse event or serious injury. As previously described, this product defect renders the diagnostic test kit unusable, but does not have the potential to harm the patient or provide an inaccurate clinical diagnosis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2011-00001 |
| MDR Report Key | 2217081 |
| Report Source | 00,06 |
| Date Received | 2011-04-14 |
| Date Mfgr Received | 2011-04-05 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-06-05 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL FRIEDMAN |
| Manufacturer Street | 24 SCHOOL ST. 6TH FLOOR |
| Manufacturer City | BOSTON MA 02108 |
| Manufacturer Country | US |
| Manufacturer Postal | 02108 |
| Manufacturer Phone | 6172344441 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | NQM |
| Date Received | 2011-04-14 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-14 |