MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-11-04 for ADVIA 120 * manufactured by Bayer Diagnostics Mfg. Ltd..
[406507]
In 2005 a lab supervisor at a hosp notified bayer that a result for a pt's platelet level of 16,000/mm3 had been reported. The laboratory stated that one week later a sample was drawn from the pt and an initial count of 16,000 platelets was obtained on an advia 120 hematology analyzer. A smear of the sample was created and a visual count was done that produced the same results. Further, a visual examination of the sample revealed that there was no evidence of clots. A second draw of the pt was done. The laboratory reported a count of 260,000 platelets on the second draw, which was confirmed on visual examination. This revised count was then reported. The pt had already been transfused with platelets at that time. A second visual review of the first sample it was determined that there was a clot in the sample that had not been observed initially on the smear. Standard good laboratory practice requires that operators presented with low platelet counts return the sample and/or check the sample for clots. In the instances cited for this event, the advia 120 result and the manual platelet count produced similar results. Improper pre-analytical handling of the specimen is the suspected cause for the platelet count discrepancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00017 |
| MDR Report Key | 645154 |
| Report Source | 06 |
| Date Received | 2005-11-04 |
| Date of Report | 2005-10-05 |
| Date of Event | 2005-09-28 |
| Date Mfgr Received | 2005-10-05 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2005-11-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANDRES HOLLE |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145843494 |
| Manufacturer G1 | BAYER DIAGNOSTIC MFG. LTD |
| Manufacturer Street | * |
| Manufacturer City | DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY SYSTEM |
| Product Code | GLK |
| Date Received | 2005-11-04 |
| Model Number | ADVIA 120 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 634642 |
| Manufacturer | BAYER DIAGNOSTICS MFG. LTD. |
| Manufacturer Address | CHAPEL LANE SWORDS CO. DUBLIN EI |
| Baseline Brand Name | ADVIA 120 |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971998 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-11-04 |