MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-03-02 for I-STAT1 ANALYZER 04P75-30 manufactured by Abbott Point Of Care.
[101586267]
Apoc incident # (b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10
[101586268]
On (b)(6) 2018, an abbott point of care distributor was contacted by a customer regarding an i-stat 1 analyzer that yielded suspected discrepant hematocrit/hemoglobin results on a patient. There was no patient information available at the time of this report. Product is available for investigation. (b)(6). The customer states that the tests for i-stat were done on the same patient less than 3 hours apart. Test/collection times are unk. There are no injuries associated with this event. At this time there is no reason to suspect a malfunction exists. The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2018-00084 |
| MDR Report Key | 7311651 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-02 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-02-04 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2001-03-12 |
| Date Added to Maude | 2018-03-02 |
| 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 |
| 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 | FLEXTRONICS MANUFACTURING (SINGAPORE) |
| Manufacturer Street | PTE LTD 1 KALLANG PLACE |
| Manufacturer City | SINGAPORE 339211 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 339211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT1 ANALYZER |
| Generic Name | I-STAT1 ANALYZER |
| Product Code | GKF |
| Date Received | 2018-03-02 |
| Returned To Mfg | 2018-03-14 |
| Model Number | NA |
| Catalog Number | 04P75-30 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Brand Name | I-STAT1 ANALYZER |
| Generic Name | I-STAT1 ANALYZER |
| Product Code | CGA |
| Date Received | 2018-03-02 |
| Returned To Mfg | 2018-03-14 |
| Model Number | NA |
| Catalog Number | 04P75-30 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-03-02 |