MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-08 for ARCHITECT SHBG 08K26 manufactured by Abbott Germany.
[74762206]
Correction/removal reporting number: 3002809144-04/18/17-001-c was too long to fit in section. A product correction letter was issued to all customers who received one or more of the architect shbg reagent lots listed below. The customers were instructed to immediately discontinue use of potassium edta specimen tube types with the architect shbg assay. A kit stuffer will be included with all current inventory advising the customer to discontinue the use of potassium edta tube types. The reagent package insert for all future lots of architect shbg has been updated to remove potassium edta tubes as an acceptable tube type for specimen collection. All in-date architect shbg lot numbers are impacted as follows: list number, lot number, manufacture date, expiration date 8k26-20, 01916e000, 13-jun-2016, 25-apr-2017 8k26-20, 00316f000, 04-jul-2016, 27-may-2017 8k26-20, 01816g000, 31-aug-2016, 12-jul-2017 8k26-20, 00916i000, 05-oct-2016, 05-sep-2017 8k26-20, 07316i000, 07-dec-2016, 21-oct-2017 8k26-20, 00916l000, 20-jan-2017, 16-dec-2017 8k26-25, 01816e000, 13-jun-2016, 25-apr-2017 8k26-25, 00216f000, 04-jul-2016, 27-may-2017 8k26-25, 01716g000, 31-aug-2016, 12-jul-2017 8k26-25, 00816i000, 05-oct-2016, 05-sep-2017 8k26-25, 07216i000, 07-dec-2016, 21-oct-2017
Patient Sequence No: 1, Text Type: N, H10
[74762207]
Abbott laboratories has identified a potential for falsely decreased architect shbg results to be generated when using the architect shbg assay with the potassium edta specimen tube type. This may also result in an increase in free androgen index / free testosterone index calculations of up to 30% when using potassium edta specimen tubes. No patient injury has been reported due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2017-00034 |
| MDR Report Key | 6552913 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-08 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-05-08 |
| 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 GERMANY |
| 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 | 3002809144-04/18/17-001- |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT SHBG |
| Generic Name | TESTOSTERONE TEST SYSTEM |
| Product Code | CDZ |
| Date Received | 2017-05-08 |
| Catalog Number | 08K26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-08 |