MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2001-08-29 for PERSONALLAB VERSION 2.2A manufactured by Biochem Immunosystems Italia S.p.a..
[209734]
A customer using the personal lab analyzer with software version 2. 2a noted that when scheduling more than one protocol in a profile and sharing a common diluent and predilution tube, some samples for the second protocol were not picked up by the metal needle and added to the predilution. There were no error messages generated. The "predil" (diluent only in the tube) is then dispensed to the plate. All samples with this error generate an invalid test result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680066-2001-00001 |
| MDR Report Key | 351167 |
| Report Source | 06,08 |
| Date Received | 2001-08-29 |
| Date of Report | 2001-08-29 |
| Date of Event | 2001-07-19 |
| Date Facility Aware | 2001-07-19 |
| Report Date | 2001-08-29 |
| Date Reported to Mfgr | 2001-07-29 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 2001-09-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | VIA LUIGI ELNAUDI, 7 GUIDONIA MONTOCELIO |
| Manufacturer City | ROME |
| Manufacturer Country | IT |
| Manufacturer Phone | 2640885 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONALLAB VERSION 2.2A |
| Generic Name | IMMUNO ASSAY ANALYZER - OPEN SYSTEM |
| Product Code | LCI |
| Date Received | 2001-08-29 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 340454 |
| Manufacturer | BIOCHEM IMMUNOSYSTEMS ITALIA S.P.A. |
| Manufacturer Address | VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO ROMA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-29 |