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 2018-12-06 for ARCHITECT IVANCOMYCIN 01P30-27 manufactured by Abbott Germany.
[130038507]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 1p30-27 that has a similar product distributed in the us, list number 1p30-28.
Patient Sequence No: 1, Text Type: N, H10
[130038508]
The customer stated that falsely decreased results of <0. 24 ug/ml were generated for two patient samples. No adverse impact to patient management was reported. Sid (b)(6): (b)(6) 2018. Initial result of <0. 24 ug/ml retested at 6. 72, 6. 73, 6. 69 and 6. 58 ug/ml. Sid (b)(6): (b)(6) 2018. Initial result of <0. 24 ug/ml retested at 7. 85, 7. 77, 7. 85 and 7. 74 ug/ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2018-00539 |
| MDR Report Key | 8139010 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-12-26 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2018-12-06 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| 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 | 2018-12-06 |
| Catalog Number | 01P30-27 |
| Lot Number | 01818B000 |
| Device Expiration Date | 2019-08-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-06 |