MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-09-12 for NONE manufactured by .
[2163103]
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Patient Sequence No: 1, Text Type: D, B5
[9328690]
(b)(6), point of care coordinator contacted amnisure regarding empty solvent vials encountered in lot a1001 on (b)(6) 2011. (b)(6) was offered replacements 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. Lisa merrill's description of the incident in uf report #(b)(4) is mostly accurate. However, the manufacturing issue cited could not result in adverse events. Thus, amnisure did not submit a 3500a form because the "mdr for manufactures" 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 in medwatch manufacturing report # 3005345832-2011-00001, 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. On (b)(6) 2011, we contacted (b)(6) to follow up and ensure all was well. She was happy with our response to their complaint and the replacements provided. They will be soon moving to a new lot of tests which was produced under the corrective actions manufactured with new vials produced with an automated process and known torque.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2011-00003 |
| MDR Report Key | 2250919 |
| Report Source | 00,06 |
| Date Received | 2011-09-12 |
| Date Mfgr Received | 2011-07-18 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-06-28 |
| 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 STREET 6TH FLOOR |
| Manufacturer City | BOSTON MA 02108 |
| Manufacturer Country | US |
| Manufacturer Postal | 02108 |
| Manufacturer Phone | 6172344441 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | NQM |
| Date Received | 2011-09-12 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-12 |