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 2017-05-18 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[75521080]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[75521081]
The customer observed multiple falsely elevated b12 results while using the architect i2000sr analyzer. The following data was provided. The customer uses normal range 138 to 652 pmol/l. Patient 1 initial 152, repeat using another analyzer 93. Patient 2 initial 232, repeat using another analyzer 152. Patient 3 initial 146, repeat using another analyzer 95. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[79039015]
As part of troubleshooting, the customer replaced the r1 and r2 probes (part 08c94-42), recalibrated the assay, and reran the quality controls. System function was verified by performing a successful calibration as well as a precision run. No additional discrepant results were reported. The analyzer was returned to normal operation. Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a labeling review, instrument log review, and an instrument service review. No returns were made available from the customer site for this evaluation. No adverse trend was identified for the customer issue. Labeling was reviewed and found to be adequate. The issue was resolved through standard troubleshooting procedures. Service history review identified no contributing factors to the customer issue. A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, a systemic issue and/or product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00223 |
| MDR Report Key | 6577308 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-18 |
| Date of Report | 2017-06-08 |
| Date Mfgr Received | 2017-05-17 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2017-05-18 |
| 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 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | CDD |
| Date Received | 2017-05-18 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-18 |
| Catalog Number | 03M74-02 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-18 |