MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-03 for I-STAT CENTRAL DATA STATION 115007 manufactured by Abbott Point Of Care Inc..
[1754747]
On (b)(6) 2010, abbott point of care was contacted by a customer who reported that the i-stat 1 analyzer provided a correct glucose result but when attached to the i-stat central data station the identification number changed from the original entered identification number, currently for unknown reasons. There was no report of any injury or impact to patient care associated with the event. Additional information is being requested from the customer.
Patient Sequence No: 1, Text Type: D, B5
[8916733]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2245578-2010-00145 |
| MDR Report Key | 1893963 |
| Report Source | 05 |
| Date Received | 2010-11-03 |
| Date of Report | 2010-11-03 |
| Date of Event | 2010-10-04 |
| Date Mfgr Received | 2010-10-04 |
| Date Added to Maude | 2011-02-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER SCOTT |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6094549270 |
| Manufacturer G1 | . |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT CENTRAL DATA STATION |
| Product Code | CDS |
| Date Received | 2010-11-03 |
| Model Number | NA |
| Catalog Number | 115007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE INC. |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-03 |