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 2018-09-21 for ARCHITECT ICT MODULE 09D28-03 manufactured by Abbott Manufacturing Inc.
[121456897]
A product recall letter was issued to all architect customers who have received the architect ict module, list number 09d28-03, lot number 180326 (180326301 through 180326399). The letter informs the customer of the issue regarding higher than expected serum or plasma chloride results for quality control and patient samples. The letter instructs the customer to discontinue use of the suspect lot and destroy any remaining inventory. The cause of the upward shift has been traced to an omitted process step during the manufacture of the chloride electrode element of the ict module.
Patient Sequence No: 1, Text Type: N, H10
[121456898]
The customer reported chloride controls shifted high out of range while using the architect ict module (list number 9d28-03, lot number 180326380). No discrepant patient results were generated and no impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01902 |
| MDR Report Key | 7899111 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2018-03-27 |
| Date Added to Maude | 2018-09-21 |
| 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 | 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1628664-08/29/18-003-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT ICT MODULE |
| Generic Name | ICT MODULE |
| Product Code | CGZ |
| Date Received | 2018-09-21 |
| Catalog Number | 09D28-03 |
| Lot Number | 180326380 |
| Device Expiration Date | 2018-12-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-09-21 |