MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-21 for ARCHITECT IVANCOMYCIN 01P30-29 manufactured by Abbott Germany.
[145674036]
All patient information has been included. No additional patient information is available. This report is being filed for an international product (list 01p30-27), that has a similar product distributed in the us (list 1p30-28). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[145674057]
The customer reported false decreased vancomycin result for a male patient when processing on the architect i1000sr. The following data was provided: sid (b)(6): initial 1. 55 ug/ml (low) and repeat 17. 2 ug/ml (high). An increased dose of vancomycin was given to sid (b)(6). It is not known if there was any adverse effect as a result of the increased dose of vancomycin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00296 |
| MDR Report Key | 8628106 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-21 |
| Date of Report | 2019-09-18 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-08-19 |
| Date Added to Maude | 2019-05-21 |
| 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 | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT GERMANY |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT IVANCOMYCIN |
| Generic Name | VANCOMYCIN |
| Product Code | LEH |
| Date Received | 2019-05-21 |
| Catalog Number | 01P30-29 |
| Lot Number | 07219A000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-21 |