MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-10 for I-STAT DATA EXCHANGER (DE) 08K46-01 manufactured by Abbott Point Of Care.
[84324853]
Apoc incident # (b)(4). The investigation was completed on 07/19/2017. The customers reported that after upgrading the i-stat/de system to version 2. 8, the reference ranges, actions ranges, and customer reportable ranges for all analytes were reset to default values; however, the preference unique identifier remained the same. This is an unexpected behavior of the i-stat/de system as the reference ranges, action ranges, and customer reportable ranges for all analytes are expected to remain the same as before the upgrade, and the preference unique identifier is expected to change whenever there is a change to any configuration setting in the analyzer's customization preferences. Testing performed at apoc, (b)(4), was able to reproduce the customers' complaint, which was attributed to an issue with the database upgrade utility included with the i-stat/de system version 2. 8 installer. A deficiency has been identified. Exception report (er) (b)(4). Has been initiated to address the issue.
Patient Sequence No: 1, Text Type: N, H10
[84324854]
On (b)(6) 2017, abbott point of care was contacted by a customer who stated that following the update to de 2. 8 all critical values have reverted to zeros. There are no injuries associated with this event. Note: the i-stat data exchange (de) system is not a medical device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2017-00274 |
| MDR Report Key | 6785767 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-08-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA MACZUSZENKO |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6136885949 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 185 CORKSTOWN ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2H 8V4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K2H 8V4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT DATA EXCHANGER (DE) |
| Generic Name | DATA EXCHANGER (DE) |
| Product Code | LNX |
| Date Received | 2017-08-10 |
| Model Number | NA |
| Catalog Number | 08K46-01 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-10 |