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 2020-03-30 for ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION 04S68-02 manufactured by Abbott Gmbh.
[188738229]
Patient information, patient identifier = sid= 1030501734013. There was no further patient information provided by the customer. Correction/removal number: 3002809144-09/18/19-008-c. Further investigation into this issue found that results could have been impacted by a deficiency of the alinity ci bulk solution level sensor, where a crack could have developed from environmental stress. A product correction letter has been issued to all worldwide customers with installed alinity i processing module and/or alinity c processing module. The letter informs the customer that the newly released bulk solution level sensor (04s68-03) will no longer be available in q4 2019 and to continue to use the bulk solution level sensor (04s68-02) with the following instructions: inspect the part for cracks prior to installation. Continue to follow the weekly maintenance procedure after installation. The letter also provides troubleshooting actions that should be taken if any of the error codes associated with a cracked alinity ci-series level sensor were received.
Patient Sequence No: 1, Text Type: N, H10
[188738230]
The customer observed false nonreactive syphilis results on a patient & error codes 1044 unable to calculate result. Final rlu read is outside the specification of the lowest calibrator, 1403 unable to process test. Final read failure when processed on the alinity i processing module. The following results were provided: on 05mar2020 sid 1030501734013; syphilis=0. 0 s/co (<1. 00=nonreactive)/repeated=6. 30 s/co (>=1. 00=reactive)/ repeated on reference instrument and syphilis results were =6. 72,6. 71 s/co. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00239 |
| MDR Report Key | 9898031 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2020-03-30 |
| 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 GMBH |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 3002809144-09/18/19-008 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTION |
| Generic Name | LEVEL SENSOR, BULK SOLUTION |
| Product Code | JJE |
| Date Received | 2020-03-30 |
| Catalog Number | 04S68-02 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GMBH |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |