MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-02-09 for ADVIA 120 * manufactured by Siemens Medical Solutions Diagnostics.
[590466]
Upon observing a failure of quality control results on an advia 120 system, the hematology lab manager determined that previously reported hemoglobin, rbc, and platelet counts were erroneously reported as higher than the actual specimen concentration. These elevated results were not detected by the hematology lab personnel until approximately 6 hrs later when they saw a higher than expected rate of delta check failures on the lis and checked the quality control results, which were out. As part of the troubleshooting effort, the operator hot washed the reagent lines which seemed to correct the issue. The samples were repeated and the hemoglobin and rbc results were lower than the original values. As result, one pt had to be called back in for a platelet transfusion. A siemens medical solutions diagnostics field service engineer (fse) was dispatched to the site and found no evidence of system malfunction. Upon review of the customer data and a discussion with the site's laboratory staff it was determined that the hgb and rbc were under diluting and giving erroneously high results. Because both parameters were affected to the same degree, the cal hbg and measured hbg agreed as did the mchc/chcm, so the results were not flagged by the instruments. Based on the actions the site operator took to correct the problem (hot washed the reagent lines) the fse determined that the reagent pump all 11 way manifold assembly on the instrument needed replacement to prevent this issue from reoccurring.
Patient Sequence No: 1, Text Type: D, B5
[7920492]
For medical device reporting purposes this event is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2007-00003 |
| MDR Report Key | 820198 |
| Report Source | 05,06 |
| Date Received | 2007-02-09 |
| Date of Report | 2007-01-16 |
| Date of Event | 2007-01-16 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2007-02-27 |
| 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 | PHILIP LIU |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242443 |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS CO, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY SYSTEM |
| Product Code | GLK |
| Date Received | 2007-02-09 |
| Model Number | ADVIA 120 |
| Catalog Number | * |
| Lot Number | NA |
| 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 | 807661 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| 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 | 2007-02-09 |