MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-26 for ADVIA AUTOSLIDE SYSTEM 10282177 manufactured by Siemens Healthcare Diagnostics Inc..
[39210255]
Siemens healthcare diagnostics inc. 's investigation determined that the advia 2120i with dual aspirate autosampler instrument did produce an error message immediately prior to the creation of the blood film slides by the advia autoslide system. Siemens healthcare diagnostics inc. Is investigating the cause of the two blood film slides being mislabeled on the advia autoslide system.
Patient Sequence No: 1, Text Type: N, H10
[39210256]
Two blood film slides were mislabeled when created on the advia autoslide system. The morphology characteristics of the blood film slides labeled with sample identification (sid) numbers (b)(6) did not match the respective complete blood counts (cbc) produced by the advia 2120i with dual aspirate autosampler instrument. The morphology characteristics of the blood film slide sid (b)(6) matched the cbc for sid (b)(6) and the morphology characteristics of sid (b)(6) matched the cbc for sid (b)(6). No erroneous results were released to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the mislabeled slides produced by the advia autoslide system.
Patient Sequence No: 1, Text Type: D, B5
[47613092]
Siemens healthcare diagnostics inc. (siemens) filed the initial mdr (2432235-2016-00095) on february 26, 2016. June 6, 2016, additional information: siemens concluded their investigation into the cause of the two blood film slides being mislabeled on the advia autoslide system and could not confirm the complaint. The customer could not provide the glass slides that were produced by the advia autoslide system nor could they provide the necessary log files for the investigation. A siemens' field service engineer visited the customer site and did not find any issues with the advia autoslide system. The cause of the two blood film slides being mislabeled on the advia autoslide system is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00095 |
| MDR Report Key | 5463527 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-26 |
| Date of Report | 2016-06-17 |
| Date of Event | 2016-02-08 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2014-01-29 |
| Date Added to Maude | 2016-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | ABX, PARC EUROMEDICINE |
| Manufacturer Street | REGISTRATION NO. 3000148879 RUE DU CHADUCEE, BP 7290 |
| Manufacturer City | MONTPELLIER, CEDEX 4, 34184 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 34184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA AUTOSLIDE SYSTEM |
| Generic Name | ADVIA AUTOSLIDE SYSTEM |
| Product Code | GKF |
| Date Received | 2016-02-26 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-26 |