MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-29 for ARCHITECT ICT MODULE 09D28-03 manufactured by Abbott Manufacturing Inc.
[118705985]
A product recall letter was issued to all architect customers who have received the architect ict module, list number 09d28-03, lot number 180326. 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
[118705986]
Abbott laboratories has confirmed higher than expected serum or plasma chloride results when using architect ict module, ln 09d28-03, lot number 180326. Based on an analysis of qc data from existing customers, the results generated using this lot number may be up to 6. 2% higher than expected. This qc analysis does not indicate an issue with urine chloride results. Additionally, since this issue only impacts the chloride electrode element of the ict module, potassium and sodium results are not impacted. There has been no report of impact to patient management due to this issue. However, there is a potential to generate falsely elevated serum or plasma chloride results. There is also the potential to delay the reporting of chloride ict results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum chloride quality control results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01620 |
| MDR Report Key | 7830570 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2018-03-26 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| 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 | 2018-08-29 |
| Catalog Number | 09D28-03 |
| Lot Number | 180326 |
| 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 | 2018-08-29 |