MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-19 for ABBOTT IVANCOMYCIN REAGENT I2000 ANALYZER manufactured by Abbott Diagnostics.
[4250250]
Abbott architect 16000 immunoassay vancomycin (ivancomycin) assay generated falsely increased test result. Operators followed manufacturer notification instructions from 2012 that all specimens must be centrifuged twice, once at normal speeds (2700 x g for 7 mins) followed by a high speed (10,000 x g spin for 15 mins) to prevent sporadically elevated results. Despite following instructions in notice, assay continues to generate sporadically increased results. Errors in elevated antibiotic results may cause the physician to withhold medication decreasing the effectiveness of the treatment. Repeat analysis of the sample (or recollection of new specimen) gives significantly lower - clinically sensible results. Continuing to use the product until we can switch the assay to another manufacturer, but physicians raising concern over risk of continued sporadic elevated results. This was one of three sporadically increased results reported by pharmacist and clinicians this week. Second patient had initial result of 49 mcg/ml, repeat result was 13 mcg/ml for a (b)(6) female patient. Third sample generated a result of greater than 100 mcg/ml, result caught by technologist, repeat was in the 2 - 3 mcg/ml range.
Patient Sequence No: 1, Text Type: D, B5
[6363365]
Abbott architect 16000 immunoassay vancomycin (ivancomycin) assay generated falsely increased test result. Operators followed manufacturer notification instructions from 2012 that all specimens must be centrifuged twice, once at normal speeds (2700 x g for 7 mins) followed by a high speed (10,000 x g spin for 15 mins) to prevent sporadically elevated results. Despite following instructions in notice, assay continues to generate sporadically increased results. Errors in elevated antibiotic results may cause the physician to withhold medication decreasing the effectiveness of the treatment. Repeat analysis of the sample (or recollection of new specimen) gives significantly lower - clinically sensible results. Continuing to use the product until we can switch the assay to another manufacturer, but physicians raising concern over risk of continued sporadic elevated results. This was one of three sporadically increased results reported by pharmacist and clinicians this week. Second patient had initial result of 49 mcg/ml, repeat result was 13 mcg/ml for a (b)(6) female patient. Third sample generated a result of greater than 100 mcg/ml, result caught by technologist, repeat was in the 2 - 3 mcg/ml range.
Patient Sequence No: 2, Text Type: D, B5
[6373624]
Abbott architect 16000 immunoassay vancomycin (ivancomycin) assay generated falsely increased test result. Operators followed manufacturer notification instructions from 2012 that all specimens must be centrifuged twice, once at normal speeds (2700 x g for 7 mins) followed by a high speed (10,000 x g spin for 15 mins) to prevent sporadically elevated results. Despite following instructions in notice, assay continues to generate sporadically increased results. Errors in elevated antibiotic results may cause the physician to withhold medication decreasing the effectiveness of the treatment. Repeat analysis of the sample (or recollection of new specimen) gives significantly lower - clinically sensible results. Continuing to use the product until we can switch the assay to another manufacturer, but physicians raising concern over risk of continued sporadic elevated results. This was one of three sporadically increased results reported by pharmacist and clinicians this week. Second patient had initial result of 49 mcg/ml, repeat result was 13 mcg/ml for a (b)(6) female patient. Third sample generated a result of greater than 100 mcg/ml, result caught by technologist, repeat was in the 2 - 3 mcg/ml range.
Patient Sequence No: 3, Text Type: D, B5
| Report Number | MW5035099 |
| MDR Report Key | 3695460 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-03-11 |
| Date Added to Maude | 2014-03-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT IVANCOMYCIN REAGENT |
| Generic Name | REAGENT |
| Product Code | LEH |
| Date Received | 2014-03-19 |
| Model Number | I2000 ANALYZER |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL US |
| Brand Name | ARCHITECT I 2000 ANALYZER |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJC |
| Date Received | 2014-03-19 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | ABBOTT PARK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-19 | |
| 2 | 0 | 2014-03-19 | |
| 3 | 0 | 2014-03-19 |