MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-19 for IMMULINK 0064327 manufactured by Immucor, Inc..
[103273309]
An immucor specialist employee assessed the software in question on (b)(6) 2018 and confirmed that the date of birth demographic information is indeed carried over from the previous sample, but the immucor specialist employee was able to establish that no other demographic information is carried over. To clarify, this issue happens when a sample that does not have patient demographics is scanned into the qiacube worklist in immulink software following a sample that does have patient demographics. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103273310]
On (b)(6) 2018, a customer site reported a label generated from immulink software that contained the wrong patient demographic information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00071 |
| MDR Report Key | 7348974 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-02-21 |
| Date Added to Maude | 2018-03-19 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR HOWARD YOREK |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 300915625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULINK |
| Generic Name | SOFTWARE, BLOOD BANK, STAND ALONE |
| Product Code | MMH |
| Date Received | 2018-03-19 |
| Catalog Number | 0064327 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-19 |