MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for ADVIA AUTOSLIDE SYSTEM 10282177 manufactured by Siemens Healthcare Diagnostics Inc.
[120717460]
The customer contacted a siemens customer care center (ccc). A siemens customer service engineer (cse) was dispatched to the customer's site. The customer suspected that the patient sample, that was ordered for testing, after the affected sample was on the affected slide. The cse inspected the instrument with the customer and siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[120717461]
A customer reported that a panel of complete blood count (cbc) results obtained on a patient sample, from a slide produced by an advia autoslide system, did not correlate with the results obtained on an advia 2120i hematology system with dual aspirate autosampler. The customer reported that the results from the advia 2120i hematology system with dual aspirate autosampler were expected. The results obtained from the slide produced on the advia autoslide system were reported to the physician(s) and questioned. The customer indicated that the slide produced by the advia autoslide system was labeled with the corrected sample id, but contained another patient's blood sample. The customer manually created a slide using the affected patient sample and stained it using a hematek instrument; the results obtained from the manually produced slide confirmed the results obtained on the advia 2120i hematology system with dual aspirate autosampler. There are no known reports of patient intervention or adverse health consequences due to the incorrect patient's blood sample produced on another patient's slide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00337 |
| MDR Report Key | 7866469 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2015-07-20 |
| Date Added to Maude | 2018-09-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | ABX, PARC EUROMEDICINE |
| Manufacturer Street | RUE DU CHADUCEE - BP7290,34184 REGISTRATION NUMBER:3000148879 |
| Manufacturer City | MONTPELLIER CEDEX 4, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA AUTOSLIDE SYSTEM |
| Generic Name | ADVIA AUTOSLIDE SYSTEM |
| Product Code | KPA |
| Date Received | 2018-09-11 |
| Model Number | ADVIA AUTOSLIDE SYSTEM |
| Catalog Number | 10282177 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |